Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- NDHNail, Fixation, Bone, Metallic2Product Code
- HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer2Product Code
- HRZProsthesis, Knee, Hinged (Metal-Metal)3Product Code
- HSAProsthesis, Knee, Hemi-, Femoral3Product Code
- HSBRod, Fixation, Intramedullary And Accessories2Product Code
- NDIStaple, Fixation, Bone, Metallic2Product Code
- HRSPlate, Fixation, Bone2Product Code
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented2Product Code
- HSHProsthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)2Product Code
- HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer2Product Code
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer2Product Code
- HTGProsthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented2Product Code
- HTNWasher, Bolt Nut2Product Code
- HTYPin, Fixation, Smooth2Product Code
- HWCScrew, Fixation, Bone2Product Code
- HXAProsthesis, Tendon, Passive2Product Code
- JDBProsthesis, Elbow, Semi-Constrained, Cemented2Product Code
- JDCProsthesis, Elbow, Constrained, Cemented2Product Code
- JDDProsthesis, Upper Femoral2Product Code
- JDGProsthesis, Hip, Femoral Component, Cemented, Metal2Product Code
- JDHProsthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal3Product Code
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2Product Code
- JDLProsthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)3Product Code
- JDNImplant, Fixation Device, Spinal2Product Code
- JDODevice, Fixation, Proximal Femoral, Implant2Product Code
- JDPCondylar Plate Fixation Implant2Product Code
- JDQCerclage, Fixation2Product Code
- JDRStaple, Fixation, Bone2Product Code
- JDSNail, Fixation, Bone2Product Code
- JDTCap, Bone1Product Code
- JDWPin, Fixation, Threaded2Product Code
- JECComponent, Traction, Invasive2Product Code
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2Product Code
- JWIProsthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained2Product Code
- JWJProsthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained2Product Code
- KIGProsthesis, Wrist, Constrained, Polymer2Product Code
- KMBProsthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented2Product Code
- KMCProsthesis, Hip, Semi-Constrained, Composite/Metal2Product Code
- KMDProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite2Product Code
- KRNMetal Cemented Constrained Femorotibial Knee Prosthesis3Product Code
- KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2Product Code
- KRPProsthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal3Product Code
- KRQProsthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer2Product Code
- KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer2Product Code
- KRSProsthesis, Knee, Hemi-, Femoral (Uncemented)3Product Code
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component2Product Code
- KTWAppliance, Fixation, Nail/Blade/Plate Combination, Single Component2Product Code
- KTXProsthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented2Product Code
- KWAProsthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)3Product Code
- KWBProsthesis, Hip, Hemi-, Acetabular, Cemented, Metal3Product Code
- KWDProsthesis, Toe, Hemi-, Phalangeal2Product Code
- KWEProsthesis, Finger, Constrained, Metal, Uncemented3Product Code
- KWFProsthesis, Finger, Polymer2Product Code
- KWGProsthesis, Finger, Constrained, Metal/Polymer3Product Code
- KWHProsthesis, Toe, Constrained, Polymer2Product Code
- KWIProsthesis, Elbow, Hemi-, Radial, Polymer2Product Code
- KWJProsthesis, Elbow, Hemi-, Humeral, Metal3Product Code
- KWKAppliance, Nail/Blade/Plate Combination, Single Component2Product Code
- KWLProsthesis, Hip, Hemi-, Femoral, Metal2Product Code
- KWMProsthesis, Wrist, Semi-Constrained2Product Code
- KWNProsthesis, Wrist, Carpal Lunate2Product Code
- KWOProsthesis, Wrist, Carpal Scaphoid2Product Code
- KWPAppliance, Fixation, Spinal Interlaminal2Product Code
- KWQAppliance, Fixation, Spinal Intervertebral Body2Product Code
- KWRProsthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented3Product Code
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented2Product Code
- KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2Product Code
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented2Product Code
- KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer2Product Code
- KXAProsthesis, Hip, Femoral, Resurfacing2Product Code
- KXBProsthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer3Product Code
- KXCProsthesis, Ankle, Cemented, Non-Constrained3Product Code
- KXDProsthesis, Hip, Constrained, Metal3Product Code
- KXEProsthesis, Wrist, Hemi-, Ulnar2Product Code
- KYIProsthesis, Wrist, Carpal Trapezium2Product Code
- KYJProsthesis, Finger, Constrained, Polymer2Product Code
- KYKProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite2Product Code
- KYMMetallic Cemented Glenoid Hemi-Shoulder Prosthesis3Product Code
- KYNProsthesis, Wrist, Constrained, Metal3Product Code
- LBCProsthesis, Finger, Constrained, Metal, Cemented3Product Code
- LGEProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing2Product Code
- LODBone Cement2Product Code
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented2Product Code
- LRNWire, Surgical2Product Code
- LTOSpacer, Cement3Product Code
- LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented2Product Code
- LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite2Product Code
- LYPAccessories, Fixation, Spinal Interlaminal2Product Code
- LYTFixation Accessory2Product Code
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2Product Code
- LZYProsthesis, Hip, Hemi-, Femoral, Metal Ball2Product Code
- MAIFastener, Fixation, Biodegradable, Soft Tissue2Product Code
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar2Product Code
- MAYProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish2Product Code
- MBBBone Cement, Antibiotic2Product Code
- MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented2Product Code
- MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer2Product Code
- MBIFastener, Fixation, Nondegradable, Soft Tissue2Product Code
- K252664GMReis Suture Anchors2Cleared 510(K)
- K252314Arthrex SutureTak Suture Anchor2Cleared 510(K)
- K253040Aevumed FASE Suture Anchor2Cleared 510(K)
- K253010Mini Superhawk Suture Anchor System2Cleared 510(K)
- K250095All-Suture Dual Anchor System2Cleared 510(K)
- K242895Aevumed PHANTOM Suture Anchors2Cleared 510(K)
- K252144Iconix Speed Anchor; Iconix Speed HA+ Anchor2Cleared 510(K)
- K251310OTS 25-L (100-5)2Cleared 510(K)
- K251809Arthrex FiberTak Suture Anchor2Cleared 510(K)
- K251145Arthrex PushLock Suture Anchors2Cleared 510(K)
- K251933SnugFit ASA Extension2Cleared 510(K)
- K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)2Cleared 510(K)
- K251530CONMED Argo Knotless® Anchor2Cleared 510(K)
- K250844PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip; RIGIDLOOP™ BTB; RIGIDLOOP™ Suture Loop2Cleared 510(K)
- K242477Shoulder Soft Tissue Anchors2Cleared 510(K)
- K250596Arthrex FiberTak Suture Anchor2Cleared 510(K)
- K243988RootMend MRR2Cleared 510(K)
- K250424Arthrex TightRope Soft Button, RT2Cleared 510(K)
- K250238WasherCap™ Fixation System2Cleared 510(K)
- K244015SuperBall-RC™2Cleared 510(K)
- K243665Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor)2Cleared 510(K)
- K243726Osprey Suture Anchor2Cleared 510(K)
- K243712WasherCap™ Mini Fixation System (Model 45)2Cleared 510(K)
- K244025Argo Knotless GENESYS Anchor2Cleared 510(K)
- K241234OTS 25-L (100-5)2Cleared 510(K)
- K242529Tigon Medical All-Suture Anchors (ASA)2Cleared 510(K)
- K243470Fix2Lock (PEEK Self Punching)2Cleared 510(K)
- K242494OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct2Cleared 510(K)
- K243323Iconix Knotless Anchor2Cleared 510(K)
- K243203OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor2Cleared 510(K)
- K241695Extremity All Suture System2Cleared 510(K)
- K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture Anchor (ATP003-M); VersaLat™ Ti Suture Anchor (ADP021-TI); VersaLat™ Suture Anchor (ADP021-PK)2Cleared 510(K)
- K233601Fixone Meniscal Repair2Cleared 510(K)
- K241864Grappler Interference Screw System2Cleared 510(K)
- K240835Suture Button Repair System2Cleared 510(K)
- K241577Iconix® Anchor2Cleared 510(K)
- K241435Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, co-braid-blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, co-braid-blue2Cleared 510(K)
- K241235Arthrex TightRope II2Cleared 510(K)
- K232941Megaloop Button System2Cleared 510(K)
- K240719OC JuggerKnot Soft Anchor2Cleared 510(K)
- K240594Grappler Suture Anchor R3FLEX IOL System2Cleared 510(K)
- K240407ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture Anchor2Cleared 510(K)
- K240213Iconix Knotless Anchor2Cleared 510(K)
- K240194ProCinch, QuadCinch2Cleared 510(K)
- K233893AlphaVent Knotless SP PEEK Anchor2Cleared 510(K)
- K233730Footprint Mini PK, 3.5mm Suture Anchor2Cleared 510(K)
- K231033CEPTRE® Knotted UHMWPE Suture PEEK Anchor2Cleared 510(K)
- K230891SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant2Cleared 510(K)
- K233659Suture Wing2Cleared 510(K)
- K233429OTS 25 (100-1)2Cleared 510(K)
- K233552IDEAL Ziploop2Cleared 510(K)
- K232973Arthrex Knee FiberTak® Button Suture Anchor2Cleared 510(K)
- K233468Iconix Anchor2Cleared 510(K)
- K232886INFILOOP® Fixed Loop UHMWPE Suture Titanium Button2Cleared 510(K)
- K232742Arthrex FiberTak Suture Anchor2Cleared 510(K)
- K232725Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor2Cleared 510(K)
- K232683Knotilus+ PEEK Knotless Anchor2Cleared 510(K)
- K233258Shadow Knotless All-Suture Anchors2Cleared 510(K)
- K2324922.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomposite Anchor2Cleared 510(K)
- K232411JuggerKnot Soft Anchor OC2Cleared 510(K)
- K231078All-Suture Anchor2Cleared 510(K)
- K232592CITRELOCK® DUO2Cleared 510(K)
- K230517Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor)2Cleared 510(K)
- K232457Q-FIX ULTRA All-Suture Anchor2Cleared 510(K)
- K232340Arthrex 2.4mm Knotless Hip SutureTak® Suture Anchor2Cleared 510(K)
- K231093AlphaVent Suture Anchors2Cleared 510(K)
- K230094Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors2Cleared 510(K)
- K231867Grappler Suture Anchor System2Cleared 510(K)
- K231376Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape)2Cleared 510(K)
- K231857Arthrex TightRope II2Cleared 510(K)
- K232005HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid)2Cleared 510(K)
- K231404T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button2Cleared 510(K)
- K223114Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors2Cleared 510(K)
- K231278Knotless Suture Anchor2Cleared 510(K)
- K231322Fix2Lock(PEEK Self Punching)2Cleared 510(K)
- K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless)2Cleared 510(K)
- K231330FiberTak® Suture Anchor2Cleared 510(K)
- K230874Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath2Cleared 510(K)
- K223860Integrity™ Bone Staple Fixation System2Cleared 510(K)
- K231113Arthrex FiberTak Suture Anchor2Cleared 510(K)
- K231128JuggerKnot Soft Anchor2Cleared 510(K)
- K230655PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw2Cleared 510(K)
- K230123Apollo Knotless Suture Anchor2Cleared 510(K)
- K230544SnugFit All-Suture Anchor extension2Cleared 510(K)
- K230568FiberTak Suture Anchor2Cleared 510(K)
- K222423Fixone All Suture Anchor2Cleared 510(K)
- K223889Stativ® Knotted UHMWPE Suture Anchor2Cleared 510(K)
- K220464Tigon Medical Gryphon Anchor Line2Cleared 510(K)
- K223878Aevumed RAPID Suture Anchors2Cleared 510(K)
- K230433Arthrex Knotless FiberTak Suture Anchor2Cleared 510(K)
- K220966SINEFIX2Cleared 510(K)
- K223589Grappler Suture Anchor R3FLEX IOL System2Cleared 510(K)
- K223582MectaLock TI Triple Loaded Suture Anchor2Cleared 510(K)
- K230212OrthoButton AL2Cleared 510(K)
- K222971ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB SMALL Adjustable Fixation Device; ULTRABUTTON TIB MEDIUM Adjustable Fixation Device; ULTRABUTTON TIB LARGE Adjustable Fixation Device2Cleared 510(K)
- K222574Simparo Anchor Line Fixation System2Cleared 510(K)
- K223284SutureLoc™ Implant2Cleared 510(K)
- K222589Flexible Suturing System with Anchors (FSSA)2Cleared 510(K)
- K223795FairFix QT Adjustable Button2Cleared 510(K)
- K221396Arthrex FiberTak Suture Anchor2Cleared 510(K)
- K213110AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor2Cleared 510(K)
- K222363Aevumed PHANTOM™-LP Suture Anchors2Cleared 510(K)
- K213018Auxilock GFS Mini, GFS II Large, and GFS Ultimate2Cleared 510(K)
- K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors2Cleared 510(K)
- K212197WasherCap Fixation System2Cleared 510(K)
- K222091Grappler Suture Anchor System2Cleared 510(K)
- K221731FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire2Cleared 510(K)
- K213109Auxilock Draw Tight Suture-Based Anchor2Cleared 510(K)
- K222169FairFix Adjustable Button System2Cleared 510(K)
- K222161Arthrex Knotless FiberTak Biceps Suture Anchor2Cleared 510(K)
- K220901S-Core Implant System2Cleared 510(K)
- K213104Auxilock Titanium Screw-In Suture Anchor2Cleared 510(K)
- K221502Parcus Synd-EZ SS2Cleared 510(K)
- K221364Mitek TIGHT-N Anchor2Cleared 510(K)
- K221389FairFix AM Adjustable Button FairFix PSP Adjustable Button2Cleared 510(K)
- K221135X-Twist PEEK Suture Anchor2Cleared 510(K)
- K220757Argo Knotless SP Anchor2Cleared 510(K)
- K220797FootHold System2Cleared 510(K)
- K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTi2Cleared 510(K)
- K212739ActiFlip2Cleared 510(K)
- K211322Paratrooper Plantar Plate Repair System2Cleared 510(K)
- K211502Alpha Vent PEEK Suture Anchor2Cleared 510(K)
- K211049Tigon Medical Button System2Cleared 510(K)
- K211002Grappler Suture Anchor System2Cleared 510(K)
- K202663Suture Wing2Cleared 510(K)
- K202763Fix2Lock (PEEK Self Punching)2Cleared 510(K)
- K203121Responsive Arthroscopy Thunderbolt System2Cleared 510(K)
- K203259FairFix Adjustable Button System2Cleared 510(K)
- K210498Betta Link Knotless Implant System2Cleared 510(K)
- K210078Stryker ProCinch Adjustable Loop Device2Cleared 510(K)
- K202662Parcus Titanium Interference Screws2Cleared 510(K)
- K203740JuggerKnot Soft Anchor2Cleared 510(K)
- K203385TenoTac Soft Tissue Fixation System2Cleared 510(K)
- K203794HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture2Cleared 510(K)
- K203485SnugFit All-Suture Anchor2Cleared 510(K)
- K202291Button Loop2Cleared 510(K)
- K192709Fixone All Suture Anchor2Cleared 510(K)
- K203268Arthrex FiberTak Suture Anchor2Cleared 510(K)
- K202883Sterile bone screw (PEEK ACL screw)2Cleared 510(K)
- K193377TopLock Anchor System2Cleared 510(K)
- K202444Knotless TensionTight Button Implant System2Cleared 510(K)
- K202355Stryker Omega PEEK Knotless Anchor System2Cleared 510(K)
- K202178VersaLoop Anchor System2Cleared 510(K)
- K200428Multi-Drive Interference Screw System2Cleared 510(K)
- K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws2Cleared 510(K)
- K202581Arthrex TightRope II2Cleared 510(K)
- K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip2Cleared 510(K)
- K202193PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament Reconstruction, PULLUP TEX CLIP Adjustable Fixation System for Ligament Reconstruction, BT LOOP Adjustable Fixation System for Ligament Reconstruction2Cleared 510(K)
- K192949Flower Suture Anchor Set2Cleared 510(K)
- K202399OrthoButton FL2Cleared 510(K)
- K202153Responsive Arthroscopy Suture Anchor System2Cleared 510(K)
- K200503ATL Anchors2Cleared 510(K)
- K201636Hercules Suture Anchor System2Cleared 510(K)
- K2018836.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor2Cleared 510(K)
- K201083Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors2Cleared 510(K)
- K200949HEALIX ADVANCE Anchor with DYNATAPE Suture2Cleared 510(K)
- K193108Bonecam Suture Anchor2Cleared 510(K)
- K200341Arthrex FiberTak Suture Anchor2Cleared 510(K)
- K192810Apollo Suture Anchor System2Cleared 510(K)
- K193402ALLthread PEEK Suture Anchor2Cleared 510(K)
- K200028Coronet Soft Tissue Fixation System2Cleared 510(K)
- K193245Dunamis PunchTac Suture Anchors2Cleared 510(K)
- K193165MectaFix CL Fixation Button with Continuous Loop2Cleared 510(K)
- K193461MectaLock All-Suture Anchors2Cleared 510(K)
- K191677MectaTap TI Suture Anchor2Cleared 510(K)
- K191227Paratrooper Plantar Plate Repair System2Cleared 510(K)
- K193295Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor2Cleared 510(K)
- K193606Y-Knot OneStep Anchor2Cleared 510(K)
- K192942ALLthread Titanium Suture Anchor2Cleared 510(K)
- K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip2Cleared 510(K)
- K193092TunneLoc Tibial Fixation Device2Cleared 510(K)
- K191426FiberTak Button2Cleared 510(K)
- K192964Parcus Synd-EZ SS2Cleared 510(K)
- K191783Parcus Synd-EZ Ti2Cleared 510(K)
- K192428AFX Femoral Implant with Inserter2Cleared 510(K)
- K191459JuggerStitch Meniscal Repair Device2Cleared 510(K)
- K190288Arthrex Tenodesis Button2Cleared 510(K)
- K191300MectaLock Ti Suture Anchor2Cleared 510(K)
- K191319Dunamis Fixation Button System2Cleared 510(K)
- K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant2Cleared 510(K)
- K191053Xtreme-Loop2Cleared 510(K)
- K191204Infinity Fixation System2Cleared 510(K)
- K190915OsteoFab Suture Anchors2Cleared 510(K)
- K191483HEALIX ADVANCE Anchor with DYNA+TAPE Sutures2Cleared 510(K)
- K190892MectaScrew PEEK Interference Screw2Cleared 510(K)
- K190474MectaLock PEEK Suture Anchor2Cleared 510(K)
- K190125FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire2Cleared 510(K)
- K190375Parcus ATLAS2Cleared 510(K)
- K190728Arthrex SwiveLock Anchors2Cleared 510(K)
- K190446Responsive Arthroscopy Wedge Push-In Suture Anchors2Cleared 510(K)
- K190333Paradigm All-Suture Anchor 1.8mm, White/Black #22Cleared 510(K)
- K183690Tenodesis Screw System2Cleared 510(K)
- K182941HEALIX ADVANCE SP PEEK Anchor2Cleared 510(K)
- K183279HEALIX Ti ANCHOR with DYNACORD2Cleared 510(K)
- K183331Parcus GFS BTB2Cleared 510(K)
- K182507Tigon Medical Tissue Anchors2Cleared 510(K)
- K181076Responsive Arthroscopy Wedge Push-In Suture Anchors2Cleared 510(K)
- K182898TenoTac Soft Tissue Fixation System2Cleared 510(K)
- K181086Cortical Fixation Systems2Cleared 510(K)
- K182439TruShot with Y-Knot Shallow All-Suture Anchor2Cleared 510(K)
- K182621CrossFT Knotless Deep Thread Suture Anchor with Disposable Driver2Cleared 510(K)
- K180951Responsive Arthroscopy Suture Anchor System2Cleared 510(K)
- K182736OIC Suture Anchor System2Cleared 510(K)
- K1811202.8 mm/3.3 mm PopLok Suture Anchors2Cleared 510(K)
- K182446TruShot with Y-Knot All-Suture Anchor2Cleared 510(K)
- K182264ICONN Revolution Knotless Suture Anchor2Cleared 510(K)
- K181769Arthrex FiberTak Suture Anchor2Cleared 510(K)
- K181513Arthrex PushLock Tenodesis Anchor2Cleared 510(K)
- K181680ICONN Answer II Suture Anchor2Cleared 510(K)
- K180759SECULOK™ Suture Anchor2Cleared 510(K)
- K173845Arthrex SwiveLock2Cleared 510(K)
- K181083Stryker All-PEEK Knotless Anchor System2Cleared 510(K)
- K180464AEVUMED PHANTOM Suture Anchors2Cleared 510(K)
- K173269KATOR Suture Anchor2Cleared 510(K)
- K173074ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor2Cleared 510(K)
- K180274Ventix Link Knotless Anchor with Inserter2Cleared 510(K)
- K180118Arthrex NanoSuture Anchor2Cleared 510(K)
- K173278ToggleLoc System2Cleared 510(K)
- K172491ICONN Square 2.5MM Suture Anchor2Cleared 510(K)
- K172921Stryker Self-Punching ICONIX2Cleared 510(K)
- K171640M-ARS ACL: Anatomic Ribbon Surgery System2Cleared 510(K)
- K172186BioWick X Implant with Driver2Cleared 510(K)
- K172612FiberTak DX2Cleared 510(K)
- K171964LigaMetrics Suture Anchors2Cleared 510(K)
- K171725CuffLink Implant System2Cleared 510(K)
- K171465Stryker Self-Punching ICONIX2Cleared 510(K)
- K172165Q-Fix Suture Anchor2Cleared 510(K)
- K170388ANCHORMAN Tibial Ligament Fixation Device2Cleared 510(K)
- K171060OrthoButton AL2Cleared 510(K)
- K170877Parcus SLiK Fix Screw2Cleared 510(K)
- K171020Arthrex Knotless SutureTak Anchor2Cleared 510(K)
- K170098ICONIX TT All Suture Anchor2Cleared 510(K)
- K170327Parcus SLiK Anchors2Cleared 510(K)
- K170265GRAVITYTM PEEK-OPTIMA Suture Anchor2Cleared 510(K)
- K163258CrossFT Knotless Suture Anchor with Disposable Driver2Cleared 510(K)
- K163034SUTUREFIX Curved Suture Anchor2Cleared 510(K)
- K162198GFS Ultimate2Cleared 510(K)
- K162386KATOR Suture Anchor2Cleared 510(K)
- K161033AFX™ Femoral Implant With Inserter2Cleared 510(K)
- K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm2Cleared 510(K)
- K161001MILAGRO ADVANCE PEEK Interference Screw2Cleared 510(K)
- K160655OrthoButton CL2Cleared 510(K)
- K160319FiberTak DR2Cleared 510(K)
- K153585Flip Button Suture Anchor2Cleared 510(K)
- K160118STROPP (Single Tunnel Repair of Plantar Plate)2Cleared 510(K)
- K153558Ventix Suture Anchor2Cleared 510(K)
- K160500Elite SPK, Compasso, Elite SPK Kit2Cleared 510(K)
- K153667TRUESPAN Meniscal Repair System2Cleared 510(K)
- K152262Ventix Knotless Anchors2Cleared 510(K)
- K151092Arthrex Short Suture Anchors2Cleared 510(K)
- K153186Adjustable Fixation Device2Cleared 510(K)
- K153669MultiFIX S Ultra Knotless Fixation System2Cleared 510(K)
- K153313SpeedLock Knotless Fixation System2Cleared 510(K)
- K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor, HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor), Bioraptor Curved 2.3 PK Suture Anchors2Cleared 510(K)
- K152711Parcus GFS Naked2Cleared 510(K)
- K151004PULLUP® Adjustable Juxtacortical Fixation Device2Cleared 510(K)
- K152255BoneCam Suture Anchors2Cleared 510(K)
- K152236KATOR Suture Anchor2Cleared 510(K)
- K151220Dunamis Interference Screw2Cleared 510(K)
- K151601SECURE-LOOP2Cleared 510(K)
- K150768JuggerKnot Soft Anchors2Cleared 510(K)
- K150648Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm2Cleared 510(K)
- K151897MultiFIX® P Knotless Fixation Device2Cleared 510(K)
- K1507152.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors2Cleared 510(K)
- K151068SureLock W Suture Anchor2Cleared 510(K)
- K151314CinchLock Flex Knotless Suture Anchor2Cleared 510(K)
- K151660MultiFIX S Knotless Fixation System2Cleared 510(K)
- K151037GraftMax Button, ALB with Cradle, GraftMax Button, BTB with Cradle2Cleared 510(K)
- K143745Arthrex Corkscrew and SwiveLock Suture Anchors2Cleared 510(K)
- K151201Stryker ICONIX with Needles2Cleared 510(K)
- K151230Arthrex FiberTak Anchors2Cleared 510(K)
- K150424JuggerStitch Meniscal Repair Device2Cleared 510(K)
- K143473Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles, Short SureLock All-Suture Anchor, 1.4mm with (1) size 2-0 UHMWPE suture with needles2Cleared 510(K)
- K150166Extremity Medical Suture Anchor2Cleared 510(K)
- K143392Quattro Bolt Tenodesis Screw2Cleared 510(K)
- K142643Stabilynx PEEK Suture Anchor2Cleared 510(K)
- K1425744.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture,2Cleared 510(K)
- K142653G-Lok and G-Lok XL Extender2Cleared 510(K)
- K142230Apollo Suture Anchor System and Titan Screws2Cleared 510(K)
- K140476ARTHREX FIBERTAK SUTURE ANCHOR2Cleared 510(K)
- K141011G-FORCE GEN 2 SUTURE ANCHOR SYSTEM2Cleared 510(K)
- K141711PONTIS 3MM SUTURE ANCHORS WITH ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE SUTURE, PONTIS ULTRA-HIGH MOLECULAR WEIGHT POLYE2Cleared 510(K)
- K140879BIOSURE HEALICOIL PK INTERFERENCE SCREW2Cleared 510(K)
- K140324RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL2Cleared 510(K)
- K133579MULTIFILAMENT STAINLESS STEEL SUTURES WITH CRIMPS2Cleared 510(K)
- K140925ACUMED SUTURE ANCHOR SYSTEM2Cleared 510(K)
- K140604MULTIFIX S KNOTLESS FIXATION SYSTEM2Cleared 510(K)
- K132724ICONN ANSWER SUTURE ANCHOR2Cleared 510(K)
- K133235THREADED PEEK K-WIRE2Cleared 510(K)
- K133777TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR2Cleared 510(K)
- K133606N8TIVE ACL ANATOMIC RECONSTRUCTION SYSTEM, N8TIVE ACL FEMORAL IMPLANT, N8TIVE ACL TIBIAL IMPLANT, VARIOUS CLASS I ANCILL2Cleared 510(K)
- K133469ACUMED SUTURE ANCHOR SYSTEM2Cleared 510(K)
- K133036APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS2Cleared 510(K)
- K133671ICONIX ALL SUTURE ANCHORS2Cleared 510(K)
- K133757GFS II STANDARD, GFS II LARGE, GFS MIMI2Cleared 510(K)
- K133229TITANIUM SUTURE ANCHOR2Cleared 510(K)
- K133727Q-FIX SUTURE ANCHOR, 1.8MM; Q-FIX SUTURE ANCHOR, 2.8MM; DRILL, DRILL GUIDE AND OBTURATOR, 1.8MM & 2.8MM, FIRSTPASS SUTU2Cleared 510(K)
- K133224Y-KNOT RC ALL-SUTURE ANCHOR, 2.8MM - DOUBLE LOADED AND TRIPLE LOADED W/ #2 HIFI SUTURES2Cleared 510(K)
- K132867SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 1.4MM, SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 2.2MM2Cleared 510(K)
- K132783EXOSHAPE DUO SOFT TISSUE FASTENER2Cleared 510(K)
- K130467POROUS MORPHIX SUTURE ANCHOR WITH FORCE FIBER SUTURE2Cleared 510(K)
- K122437NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS2Cleared 510(K)
- K132461A.I.M. SUTURE ANCHOR2Cleared 510(K)
- K131769CINCHLOCK KNOTLESS SUTURE ANCHOR, NANOTACK SUTURE ANCHOR 1.4MM2Cleared 510(K)
- K132632TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES2Cleared 510(K)
- K132513Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM AND 2.8MM /BONE PUNCH,2.8MM AND KNOT PUSHER2Cleared 510(K)
- K1325905.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, 6.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, INSERTION GUIDE WITH OBTURATOR, TA2Cleared 510(K)
- K131635ROTATION MEDICAL BONE STAPLE (RMB STAPLE)2Cleared 510(K)
- K131325QUATTRO GL SUTURE ANCHOR2Cleared 510(K)
- K130814RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM2Cleared 510(K)
- K130033TOGGLELOC XTENDER; TOGGLELOC XL; IMPLANT KIT TOGGLELOC; IMPLANT KIT TOGGLELOC BTB, EXTENDED TOGGLELOC; TOGGLELOC; BTB TO2Cleared 510(K)
- K131182MULTIFIX S KNOTLESS FIXATION DEVICE2Cleared 510(K)
- K131035Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM2Cleared 510(K)
- K131683HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM)2Cleared 510(K)
- K130217ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM2Cleared 510(K)
- K130539HEALIX ADVANCE KNOTLESS PEEK ANCHOR (4.75MM)(5.5MM)2Cleared 510(K)
- K130458KNOTLESS FIBERTAK SUTURE ANCHOR2Cleared 510(K)
- K123485JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOF2Cleared 510(K)
- K122059ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORS2Cleared 510(K)
- K130351NANOTACK SUTURE ANCHOR 1.4MM WITH FLEX INSERTER2Cleared 510(K)
- K123350ECLIPSE SOFT TISSUE FASTENER2Cleared 510(K)
- K120740COLS® FIXATION SYSTEM2Cleared 510(K)
- K130196SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR2Cleared 510(K)
- K123651CINCHLOCK KNOTLESS SUTURE ANCHOR2Cleared 510(K)
- K123425TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL2Cleared 510(K)
- K123240SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT2Cleared 510(K)
- K122805PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR2Cleared 510(K)
- K123579FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL2Cleared 510(K)
- K122336Q-FIX SUTURE ANCHOR, 1.8MM Q-FIX ACCESS TOOLS (DRILL GUIDE W/OBTURATOR, DRILL BIT) 1.8MM2Cleared 510(K)
- K123341ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX BICEPS BUTTON, ARTHREX PROXIMAL BICEPS BUTTON2Cleared 510(K)
- K122954CINCHER-2.6 SUTURE ANCHOR MODEL FG-0012Cleared 510(K)
- K120356NCS FISH-FIT MD SYSTEM FISH-FIT MD COMPASS MD2Cleared 510(K)
- K121354MICRO/MINI N-PK(F) BONE ANCHOR2Cleared 510(K)
- K121356MICRO/MINI N-PK(H) BONE ANCHOR2Cleared 510(K)
- K122314QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY2Cleared 510(K)
- K122463APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W2Cleared 510(K)
- K1221236-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPERED2Cleared 510(K)
- K120943SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT SPEEDLOCK HIP DRILL SPEEDLOCK HIP GUIDE CROWN TIP SPEEDLOCK HIP PATHFINDER2Cleared 510(K)
- K120509STRYKER ALL SUTURE ANCHORS2Cleared 510(K)
- K1208243.9MM REELX STT SUTURE ANCHOR SYSTEM2Cleared 510(K)
- K121018BIORAPTOR 2.9, BIORAPTOR 2.3 PK, OSTEORAPTOR, & BIORAPTOR KNOTLESS SUTURE AN2Cleared 510(K)
- K120841APPIANFX SUTURE ANCHOR (6MM) (5MM) APPIANFX TISSUE ANCHOR2Cleared 510(K)
- K120942PARCUS TWIST 4 5MM PEEK SUTURE ANCHOR, PARCUS TWIST 5.5MM PEEK SUTURE ANCHOR & PARCUS TRIPLE TWIST 5.5MM PEEK SUTURE ANC2Cleared 510(K)
- K120096MULTIFIX P KNOTLESS FIXATION DEVICE2Cleared 510(K)
- K113274FOOTPRINT ULTRA PK SUTURE ANCHOR2Cleared 510(K)
- K113297KNOTILUS ANCHOR SYSTEM2Cleared 510(K)
- K120155ARTHREX KNOTLESS SUTURETAK ANCHOR2Cleared 510(K)
- K112526TWINFIX ULTRA TI, TWINFIX ULTRA PK, TWINFIX ULTRA HA SUTURE ANCHORS2Cleared 510(K)
- K113294SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR2Cleared 510(K)
- K113730PARCUS 35 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS, PARCUS 45 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS2Cleared 510(K)
- K112814CUFFINK2Cleared 510(K)
- K112417VARIOUS2Cleared 510(K)
- K112960LABRALINK SUTURE ANCHOR WITH INSERTER, 2.9MM PER-LOADED WITH ONE (1) AND (2) #2 UHMWPE SUTURE2Cleared 510(K)
- K113299ROG SUTURE ANCHOR2Cleared 510(K)
- K112876CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK SP(TM) KNOTLESS ANCHOR WITH INSERTER, 4.52Cleared 510(K)
- K112991MODIFIED ROG SUTURE ANCHOR2Cleared 510(K)
- K112296LATERAL BUTTON2Cleared 510(K)
- K111716KNOTLESS SUTURE FIXATION SYSTEM2Cleared 510(K)
- K112965NANO SUTURE ANCHOR2Cleared 510(K)
- K110800META-LOCK SUTURE ANCHOR SYSTEM2Cleared 510(K)
- K111661ARTHREX SCAPHOLUNATE ANCHOR2Cleared 510(K)
- K110879BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR2Cleared 510(K)
- K111044SPEEDLOCK KNOTLESS FIXATION DEVICE; 3.0MM DRILL; SHARP TIPPED OBTURATOR; LOW PROFILE DRILL GUIDDE2Cleared 510(K)
- K111779Y-KNOT ALL-SUTURE ANCHOR MODEL HF132Cleared 510(K)
- K111590ROG SUTURE ANCHOR, ROG KNOTLESS SUTURE ANCHOR2Cleared 510(K)
- K111631GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED SUTURE ANCHOR, ROTATOR CUFF ANCHOR / ROTATOR CUFF QUICK AN..2Cleared 510(K)
- K111399SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-752Cleared 510(K)
- K111397TITAN TI SUTURE ANCHOR SYSTEM2Cleared 510(K)
- K110545SMITH & NEPHEW NEXT GENERATION FULLY THREADED PEEK SUTURE ANCHOR (NGFTSA PK)2Cleared 510(K)
- K111564MAXFIRE MARXMEN MENISCAL REPAIR DEVICE2Cleared 510(K)
- K111471EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE)2Cleared 510(K)
- K110773TORNIER INSITE FT SUTURE ANCHOR2Cleared 510(K)
- K1107815.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES, EXTRACTION TOOL, 5.5 / 6.5MM PUNCH TAP2Cleared 510(K)
- K110473NANOTACK SUTURE ANCHOR 1.4MM2Cleared 510(K)
- K110230ROG KNOTLESS SUTURE ANCHOR2Cleared 510(K)
- K110229ROG SUTURE ANCHOR 5.5MM, 2.9MM2Cleared 510(K)
- K103262QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM2Cleared 510(K)
- K110145BIOMET SPORTS MEDICINE JUGGERKNOT SOFT ANCHOR2Cleared 510(K)
- K102539ICUFF REPAIR PLATE, RIGHT; CUFF REPAIR PLATE. LEFT; ANCHOR BOLT, 10MM THROUGH 50MM2Cleared 510(K)
- K103145HAMMERLOC TM TIBIAL FIXATION DEVICE2Cleared 510(K)
- K1101645.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL2Cleared 510(K)
- K101616THE GRAPPLR AND GRAPPLR EXTENDER2Cleared 510(K)
- K103060ARTHREX TIBIAL GRAFTBOLT2Cleared 510(K)
- K102660BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS2Cleared 510(K)
- K101126PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS2Cleared 510(K)
- K101437SPEEDFIX SUTURE SYSTEM2Cleared 510(K)
- K102262ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM; PUNCH TAP ; EXTRACTION TOOL2Cleared 510(K)
- K102443INTRAFIX TIBIAL SHEATH2Cleared 510(K)
- K101063SLEEVE WITH ZIPLOOP FIXATION DEVICES2Cleared 510(K)
- K101448OPUS SPEEDSCREW SYSTEM2Cleared 510(K)
- K100630G-FORCE PEEK SUTURE ANCHOR SYSTEM2Cleared 510(K)
- K101175KFX APPIANFX PEEK FEMORAL IMPLANT WITH INSERTER2Cleared 510(K)
- K101184TITAN TI SUTURE ANCHOR SYSTEM, MODELS 22-9055, 22-9055N, 22-9065, 22-9065N, 22-9022, 22-9005,, 22-90062Cleared 510(K)
- K100159SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR2Cleared 510(K)
- K093935SMITH & NEPHEW FOOTPRINT RCX PK SUTURE ANCHOR2Cleared 510(K)
- K100579G-FORCE TI SUTURE ANCHOR SYSTEM2Cleared 510(K)
- K093912ARTHREX TIBIAL GRAFTBOLT2Cleared 510(K)
- K093943BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM2Cleared 510(K)
- K093897SMITH & NEPHEW FOOTPRINT ULTRA PK SUTURE ANCHOR2Cleared 510(K)
- K092836OMNISPAN MENISCAL REPAIR SYSTEM/0 DEGREE, MODEL 228140, RAPIDLOC A2 MENISCAL REPAIR SYSTEM/12 DEGREE, MODEL 2281412Cleared 510(K)
- K092998CONMED LINVATEC INTERCEPT IMPLANT2Cleared 510(K)
- K093428SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR2Cleared 510(K)
- K093228SMITH & NEPHEW TWINFIX ULTRA PK SUTURE ANCHOR2Cleared 510(K)
- K092914WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES2Cleared 510(K)
- K091094PARCUS V-LOX PEEK CF SUTURE ANCHOR, MODELS: 10253, 10254, 10263, 102642Cleared 510(K)
- K091870TORNIER, PITON FIXATION IMPLANT SYSTEM2Cleared 510(K)
- K090923PARCUS GRAFT FIXATION SYSTEM2Cleared 510(K)
- K091549CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM2Cleared 510(K)
- K091503MAGNUM MP FIXATION DEVICE2Cleared 510(K)
- K090615OPUS SPEEDLOCK KNOTLESS FIXATION DEVICE2Cleared 510(K)
- K090530SPIN-LOC SUTURE ANCHOR SYSTEM FG-0302-01,FG-0305-012Cleared 510(K)
- K090380MAGNUM M FIXATION DEVICE2Cleared 510(K)
- K090075PARCUS V-LOX TITANIUM SUTURE ANCHOR,MODELS: 10251, 10252, 10257, 102582Cleared 510(K)
- K083609KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER HANDLE2Cleared 510(K)
- K083635SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREW2Cleared 510(K)
- K083226SMITH & NEPHEW PEEK INTERFERENCE SCREW2Cleared 510(K)
- K083151EXTREMITY MEDICAL SUTURE ANCHOR2Cleared 510(K)
- K083150G-FORCE TENODESIS SCREW2Cleared 510(K)
- K083240OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES2Cleared 510(K)
- K082729RIMCLOSE BONE ANCHOR2Cleared 510(K)
- K083070TOGGLELOC SYSTEM2Cleared 510(K)
- K081348TENODESIS CROSS SCREW, INTERFERENCE SCREW, SUTURE BEAD2Cleared 510(K)
- K0815112.0 PK SUTURE ANCHOR T, 2.0 PK SUTURE ANCHOR S2Cleared 510(K)
- K081497OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (MODEL OM-1502), OPUS MAGNUM X KNOTLESS FIXATION DEVICE (MODEL OM-1503)2Cleared 510(K)
- K081598SUTURE LOCK NAIL BONE ANCHOR WITH WHITE (KFX-W-200) & BLUE (KFX-B-200) FIBERFORCE SUTURE2Cleared 510(K)
- K080447SURGICRAFT SCREW FIXATION SYSTEM2Cleared 510(K)
- K080335TORNIER CINCH KNOTLESS FIXATION IMPLANT SYSTEM2Cleared 510(K)
- K0802295.5 MM SUTURE LOCK BONE SCREW ANCHOR2Cleared 510(K)
- K073481THREVO ANCHOR, DISPOSABLE DRIVER, HI-FI SUTURES2Cleared 510(K)
- K073226CINCH KNOTLESS FIXATION IMPLANT SYSTEM2Cleared 510(K)
- K072063KFX TISSUE FIXATION SYSTEM AND ACCESSORIES2Cleared 510(K)
- K070773AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHOR2Cleared 510(K)
- K071704SLEEVE AND BUTTON SOFT TISSUE DEVICES2Cleared 510(K)
- K070780CONMED LINVATEC XO BUTTON2Cleared 510(K)
- K071586BIORAPTOR 2.3 PK SUTURE ANCHOR2Cleared 510(K)
- K071520RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X2Cleared 510(K)
- K071374OPUS TWINLOCK KNOTLESS FIXATION DEVICE2Cleared 510(K)
- K070882STRYKER PEEK TWINLOOP TAC2Cleared 510(K)
- K071569ALLTHREAD PEEK ANCHOR WITH TANTALUM MARKER2Cleared 510(K)
- K070908SMITH & NEPHEW KINSA RC SUTURE ANCHOR2Cleared 510(K)
- K070758STRYKER PEEK ZIP SUTURE ANCHOR2Cleared 510(K)
- K070227OPUS MAGNUM PI KNOTLESS FIXATION DEVICE2Cleared 510(K)
- K070167ENDOBUTTON DIRECT2Cleared 510(K)
- K062739CINCH BONE ANCHOR SYSTEM2Cleared 510(K)
- K063577FEMORAL INTRAFIX SCREW AND SHEATH2Cleared 510(K)
- K063499MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM2Cleared 510(K)
- K061294KFX KNOTLESS FIXATION SYSTEM2Cleared 510(K)
- K061349OPUS LABRALOCK P KNOTLESS FIXATION DEVICE2Cleared 510(K)
- K061154KINSA SUTURE ANCHOR2Cleared 510(K)
- K053461EZLOC FEMORAL FIXATION DEVICE2Cleared 510(K)
- K052810SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM2Cleared 510(K)
- K052572ANSPACH KNOTLESS ANCHOR2Cleared 510(K)
- K052491AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR2Cleared 510(K)
- K051069NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER2Cleared 510(K)
- K050227THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER2Cleared 510(K)
- K042914OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE2Cleared 510(K)
- K042460TI - SCREW ANCHOR SP2Cleared 510(K)
- K041713SUPER REVO HERCULINE SUTURE ANCHOR2Cleared 510(K)
- K041440OPUS MAGNUM ANCHOR WITH INSERTER2Cleared 510(K)
- K041310STRYKER WEDGE SUTURE ANCHOR SYSTEM2Cleared 510(K)
- K041261FEMORAL HOOK2Cleared 510(K)
- K033838TITANIUM TOGGLE BUTTON(S)2Cleared 510(K)
- K023963ADHOC CLAW2Cleared 510(K)
- K022853ENDOTACK2Cleared 510(K)
- K022827ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR2Cleared 510(K)
- K022207AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM2Cleared 510(K)
- K020172OPUS MAGNUM ANCHOR & INSTRUMENT SET2Cleared 510(K)
- K013553PRE-LOADED ULTRAFIX RC2Cleared 510(K)
- K013334ENDOFLIP2Cleared 510(K)
- K013557LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW2Cleared 510(K)
- K012503METAL SCREW ANCHOR2Cleared 510(K)
- K011912MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 20002Cleared 510(K)
- K011007TENODESIS SCREW, 5.5 MM, MODEL AR-1350-552Cleared 510(K)
- K011390BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM2Cleared 510(K)
- K010457ARTHREX TWISTLOC SUTURE ANCHOR, MODEL AR-19242Cleared 510(K)
- K002829DJ ORTHOPEDICS FEMORAL ANCHOR2Cleared 510(K)
- K003971AXYA MEDICAL, INC. MODEL 1000 AXYALOOP BONE ANCHOR2Cleared 510(K)
- K003960DJ ORTHOPEDICS TIBIAL ANCHOR2Cleared 510(K)
- K003648FREEDLAND TENSION SYSTEM2Cleared 510(K)
- K010121STERILE BUTTON PLATE2Cleared 510(K)
- K002600LITWIN CRUICATE ANCHOR2Cleared 510(K)
- K994364SYNTHES BUTTON PLATE2Cleared 510(K)
- K000279STAPLETAC2 BONE ANCHOR SYSTEM2Cleared 510(K)
- K993657ACUMED SUTURE ANCHOR2Cleared 510(K)
- K993261TALON ANCHOR SNAP-PAK2Cleared 510(K)
- K992458RC MULTISUTURE BONE ANCHOR, MODEL 4453/44542Cleared 510(K)
- K992377RC TACK2Cleared 510(K)
- K990295BONE ANCHOR SYSTEM III (BAS III)2Cleared 510(K)
- K990156MULTITAK SS BUTTONS2Cleared 510(K)
- K990160MICROTAC-BONE ANCHOR SYSTEM2Cleared 510(K)
- K990095STRAIGHT-IN-ORTHOPEDIC BONE SCREW FIXATION SYSTEM2Cleared 510(K)
- K982751IMPLEX SCREW AND WASHER SYSTEM2Cleared 510(K)
- K983560INNOVASIVE DEVICES INTRATUNNEL TIBIAL FIXATION FASTENER2Cleared 510(K)
- K984200STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE2Cleared 510(K)
- K983557STRYKER WEDGE SUTURE ANCHOR2Cleared 510(K)
- K983169POLYMER THREADED ANCHOR2Cleared 510(K)
- K983818MITEK FASTIN RC ANCHOR2Cleared 510(K)
- K983056INNOVASIVE TIBIAL FASTENER2Cleared 510(K)
- K982571KSEA FLIPPTACK2Cleared 510(K)
- K982169SHERLOCK THREADED SUTURE ANCHOR (TIN COATED)2Cleared 510(K)
- K982155SHORT STRAIGHT-IN BONE SCREW FIXATION SYSTEM2Cleared 510(K)
- K9748475.0MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22255, 3.5MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-222352Cleared 510(K)
- K981692MENISCAL REPAIR DEVICE2Cleared 510(K)
- K981967WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCRE2Cleared 510(K)
- K981764LM ANCHOR2Cleared 510(K)
- K981755LM ANCHOR2Cleared 510(K)
- K981688ANSPACH SUTURE ANCHOR2Cleared 510(K)
- K981193INNOVASIVE 3.5MM METAL ROC XS SUTURE BONE FASTENER2Cleared 510(K)
- K980595DEPUY ORTHOTECH CATERA SUTURE ANCHOR2Cleared 510(K)
- K980491INNOVASIVE LINX TIBIAL LIGAMENT FASTENER2Cleared 510(K)
- K980334INNOVASIVE 10MM LINX HT LIGAMENT FASTENER2Cleared 510(K)
- K973874ACL CLIP-IN PLATE2Cleared 510(K)
- K973775HARPOON SUTURE ANCHORS2Cleared 510(K)
- K980103ACUMED SUTURE ANCHOR2Cleared 510(K)
- K974049INNOVASIVE LINX BT 10MM LIGAMENT FASTENER2Cleared 510(K)
- K974345MITEK KNOTLESS ANCHOR2Cleared 510(K)
- K972326PEBA ANCHOR/SUTURE COMBINATION2Cleared 510(K)
- K974136CRANIOFACIAL ANCHORS2Cleared 510(K)
- K970119MITEK ABSORBABLE POLYDIOXANONE (PDS) H FIX2Cleared 510(K)
- K973323ACL CLIP-IN2Cleared 510(K)
- K973009MITEK NON ABSORBABLE POLYPROPYLENE H FIX2Cleared 510(K)
- K963502CSCO FOREHEAD FIXATION SYSTEM2Cleared 510(K)
- K973015MULTITAK SS SUTURE SYSTEM2Cleared 510(K)
- K972622STRAIGHT-IN BONE SCREW FIXATION SYSTEM2Cleared 510(K)
- K972438INNOVASIVE 2.3MM ROC XS SUTURE BONE FASTENER2Cleared 510(K)
- K972356INNOVASIVE 2.3MM ROC EZ SUTURE BONE FASTENER2Cleared 510(K)
- K971922INNOVASIVE 2.8MM AND 3.5MM ROC EZ SUTURE BONE FASTENER2Cleared 510(K)
- K971791VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION2Cleared 510(K)
- K971802VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION2Cleared 510(K)
- K971723FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM)2Cleared 510(K)
- K971332AMS MAINSTAY UROLOGIC BONE ANCHOR2Cleared 510(K)
- K971282ANCHORLOK AND ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM2Cleared 510(K)
- K971139BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT2Cleared 510(K)
- K971144MULTITAK SS SUTURE SYSTEM2Cleared 510(K)
- K963932PRELOADED SOFT TISSUE ANCHOR2Cleared 510(K)
- K970423INNOVASIVE ROCLET BONE TUNNEL AUGMENTATION DEVICE2Cleared 510(K)
- K970292IN-FAST BONE SCREW SYSTEM/IN-FAST BONE SCREW INSERTER/IN-FAST BONE SCREW2Cleared 510(K)
- K970316INNOVASIVE 8MM LIGAMENT FASTENER2Cleared 510(K)
- K970089INNOVASIVE 2.8MM AND 3.5MM ROC LF SUTURE BONE FASTENER2Cleared 510(K)
- K964945INNOVASIVE DEVICES ROTATOR CUFF FASTNER2Cleared 510(K)
- K965111STABILIZER SOFT TISSUE ANCHOR MODEL NUMBER TA1005, TA1008, ANCHOR INSERTER/SUTURE ORGANIZER MODEL NUMBERS AI1005, AI10082Cleared 510(K)
- K965069ANSPACH SUTURE ANCHOR2Cleared 510(K)
- K964927STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE ORGANIZER, 8MM MODEL AI1008, STABILIZER DRILL, 82Cleared 510(K)
- K964786ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM2Cleared 510(K)
- K964532MULTITAK SS SUTURE SYSTEM2Cleared 510(K)
- K964324MULTITAK SS SUTURE SYSTEM2Cleared 510(K)
- K963686ANSPACH SUTURE ANCHOR (MODIFIED)2Cleared 510(K)
- K963288LM BONE ANCHOR2Cleared 510(K)
- K963812LM BONE ANCHOR (ORTHOPEDICS)2Cleared 510(K)
- K962511MITEK MICRO ANCHOR2Cleared 510(K)
- K963402INNOVASIVE 2.8MM ROC SUTURE BONE FASTENER AND 3.5MM ROC SUTURE BONE FASTENER2Cleared 510(K)
- K961094MITEK THREADED ANCHOR (MODIFICATION)2Cleared 510(K)
- K963217ANCHORLOK II SOFT TISSUE ANCHOR SYSTEM2Cleared 510(K)
- K963200QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM2Cleared 510(K)
- K962397STATAK SOFT TISSUE ATTACHMENT DEVICE2Cleared 510(K)
- K962194MLI SOFT TISSUE SCREW & WASHER SYSTEM2Cleared 510(K)
- K960825LM ANCHOR OR OTHER PROPRIETARY NAME2Cleared 510(K)
- K954683QUESTLOCK ACL FIXATOR2Cleared 510(K)
- K960516FASTAK SUTURE ANCHOR2Cleared 510(K)
- K960439LM BONE ANCHOR2Cleared 510(K)
- K960448LM ANCHOR2Cleared 510(K)
- K934183BONUTTI ANCHOR2Cleared 510(K)
- K954338INNOVASIVE 1.9MM ROC SUTURE BONE FASTENER2Cleared 510(K)
- K953954PRELOADED SOFT TISSUE ANCHOR2Cleared 510(K)
- K953560MITEK THREADED ANCHOR (FASTIN)2Cleared 510(K)
- K953877MITEK GII ANCHOR2Cleared 510(K)
- K952237INNOVASICE 2.8MM & 3.5MM ROC SUTURE BONE FASTENER2Cleared 510(K)
- K951451PEBA ANCHOR (MULTIPLE SIZES)2Cleared 510(K)
- K953702WASHER2Cleared 510(K)
- K953264QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM2Cleared 510(K)
- K934327ARTHREX SUTURE ANCHOR SCREW SYSTEM2Cleared 510(K)
- K951565INNOVASIVE DEVICES ROTATOR CUFF FASTENER2Cleared 510(K)
- K953459ACUFEX TAG ANCHOR2Cleared 510(K)
- K944831INNOVASIVE 1.9MM, 2.8MM, 3.5MM, 4.5MM ROC SUTURE BONE FASTENER2Cleared 510(K)
- MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous2Product Code
- MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)2Product Code
- MBVProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer2Product Code
- MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate2Product Code
- MJWProsthesis, Subtalar, Plug, Polymer2Product Code
- MNHOrthosis, Spondylolisthesis Spinal Fixation2Product Code
- MNIOrthosis, Spinal Pedicle Fixation2Product Code
- MNUStaple, Absorbable2Product Code
- MQPSpinal Vertebral Body Replacement Device2Product Code
- MQVFiller, Bone Void, Calcium Compound2Product Code
- MRYAppliances And Accessories, Fixation, Bone, Absorbable Single/Multiple Component2Product Code
- NDDCerclage, Fixation, Metallic2Product Code
- NDERod, Fixation, Intramedullary And Accessories, Metallic And Non-Collapsible2Product Code
- NDFPlate, Fixation, Bone, Non-Spinal, Metallic2Product Code
- NDGWasher, Bolt, Nut, Non-Spinal, Metallic2Product Code
- NDJScrew, Fixation, Bone, Non-Spinal, Metallic2Product Code
- NDKSystem, External Fixator (With Metallic Invasive Components)2Product Code
- NDLPin, Fixation, Smooth, Metallic2Product Code
- NDMPin, Fixation, Threaded, Metallic2Product Code
- NDNCement, Bone, Vertebroplasty2Product Code
- NJAAccessory, System, External Fixator, Containing Antimicrobial Agent2Product Code
- NJDProsthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer2Product Code
- NKBThoracolumbosacral Pedicle Screw System2Product Code
- NKGPosterior Cervical Screw System2Product Code
- NOVAnchor, Suture, Bone Fixation, Metallic2Product Code
- NPJProsthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2Product Code
- NQPPosterior Metal/Polymer Spinal System, Fusion2Product Code
- NQWOrthosis, Spine, Plate, Laminoplasty, Metal2Product Code
- NUDVertebroplasty Compound, Calcium Based2Product Code
- NVCBone, Heterograft3Product Code
- NWNLaparoscopic Bone Anchor Urethropexy Instrument Kit2Product Code
- OBLCement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty2Product Code
- OBMCement, Bone, Vertebroplasty, Pre-Formed, Modular2Product Code
- OBTPlate, Bone, Growth Control, Pediatric, Epiphysiodesis2Product Code
- OCGProsthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented3Product Code
- ODPIntervertebral Fusion Device With Bone Graft, Cervical2Product Code
- OISCalcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation2Product Code
- OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive2Product Code
- OJBResorbable Spinal Intervertebral Body Fixation Orthosis - Plate2Product Code
- OJMResorbable Spinal Intervertebral Body Fixation Orthosis - Mesh2Product Code
- OOGKnee Arthroplasty Implantation System2Product Code
- OOLElectronic Depth Gauge2Product Code
- OQBIntervertebral Body Graft Containment Device2Product Code
- OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented2Product Code
- OQHHip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented2Product Code
- OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented2Product Code
- OSHPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis2Product Code
- OSNSoftware For Diagnosis/Treatment2Product Code
- OURSacroiliac Joint Fixation2Product Code
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar2Product Code
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical2Product Code
- OVZPin, Fixation, Resorbable, Hard Tissue2Product Code
- OWIBone Fixation Cerclage, Sublaminar2Product Code
- OYKAnkle Arthroplasty Implantation System2Product Code
- OZIInternal Hinged Elbow Fixator2Product Code
- PAOProsthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented2Product Code
- PBFOrthopaedic Surgical Planning And Instrument Guides2Product Code
- PBIProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive2Product Code
- PEKSpinous Process Plate2Product Code
- PHMIntervertebral Fusion Device With Bone Graft, Thoracic2Product Code
- PHQAnterior Staple As Supplemental Fixation For Fusion2Product Code
- PHXShoulder Prosthesis, Reverse Configuration2Product Code
- PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained2Product Code
- PLFBone Wedge2Product Code
- PLRSpinal Vertebral Body Replacement Device - Cervical2Product Code
- PLWAcetabular Cup Orientation System2Product Code
- PMLBone Cement, Posterior Screw Augmentation2Product Code
- PPQTranstibial Anterior Cruciate Ligament Kit2Product Code
- QHQTotal Shoulder Arthroplasty System2Product Code
- PQCPedicle Screw Placement Guide2Product Code
- QACScrew Sleeve Bone Fixation Device2Product Code
- QADRod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated2Product Code
- QFPIntraoperative Orthopedic Strain Sensor2Product Code
- QHEShoulder Arthroplasty Implantation System2Product Code
- QNIResorbable Implant For Anterior Cruciate Ligament (Acl) Repair2Product Code
- QPPImplantable Post-Surgical Kinematic Measurement Knee Device2Product Code
- QPQShoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed2Product Code
- JDJMesh, Surgical, Acetabular, Hip, Prosthesis2Product Code
- JDKProsthesis, Hip, Cement Restrictor2Product Code
- LZNCement Obturator2Product Code
- OLCScaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen2Product Code
- QSDPosterior Cervical Screw Placement Guide2Product Code
- QSRSacroiliac Screw Placement Guide2Product Code
- QVIScrew Sleeve Bone Fixation Device, Spine2Product Code
- QUWMesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament2Product Code
- QWJMesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament2Product Code
- SAIAnkle Fusion Cage2Product Code
- SCYSacroiliac Joint Guidewire Placement Device2Product Code
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
ATL Anchors
- Page Type
- Cleared 510(K)
- 510(k) Number
- K200503
- 510(k) Type
- Traditional
- Applicant
- International Life Sciences
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/2/2020
- Days to Decision
- 184 days
- Submission Type
- Summary