Anesthesiology
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- 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
- K243760OSSIOfiber® Suture Anchor 2.5-3.5 mm2Cleared 510(K)
- K250526Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor2Cleared 510(K)
- K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor2Cleared 510(K)
- K243467Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)2Cleared 510(K)
- K241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors2Cleared 510(K)
- K241912BIOCHARGE2Cleared 510(K)
- K233971Arthrex AlloSync PushLock Suture Anchor2Cleared 510(K)
- K240288SF Push- in Anchor2Cleared 510(K)
- K240441MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw2Cleared 510(K)
- K240090Argo Knotless GENESYS Anchor2Cleared 510(K)
- K232513X-Twist Biocomposite Suture Anchor2Cleared 510(K)
- K231787ecoFIX®2Cleared 510(K)
- K231641Rotium Bioresorbable Wick2Cleared 510(K)
- K230892Fixone Biocomposite Anchor2Cleared 510(K)
- K231326Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)2Cleared 510(K)
- K230394EUROSCREW NG; EUROSCREW TCP NG2Cleared 510(K)
- K230435Arthrex 3.9 mm SwiveLock Anchor2Cleared 510(K)
- K221468Citregen™ Tendon Interference Screw (TIS), Citrelock™ Tendon Fixation Device, Citrespline™ and Citrelock™ ACL Implants2Cleared 510(K)
- K220833Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL2Cleared 510(K)
- K221128Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II2Cleared 510(K)
- K222263Arthrex Self Punching SwiveLock Suture Anchors2Cleared 510(K)
- K221099Arthrex Self-Punching PushLock Suture Anchor2Cleared 510(K)
- K213958Bioabsorbable Anchor2Cleared 510(K)
- K213415OSSIOfiber Suture Anchor2Cleared 510(K)
- K203523Fixone hybrid knotless anchor2Cleared 510(K)
- K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System2Cleared 510(K)
- K210122Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)2Cleared 510(K)
- K202806Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)2Cleared 510(K)
- K203495Arthrex SwiveLock Anchor2Cleared 510(K)
- K210239CITRESPLINE and CITRELOCK ACL Implants2Cleared 510(K)
- K203493MectaLock Extension2Cleared 510(K)
- K203334The Citrefix Knotless Suture Anchor2Cleared 510(K)
- K202535Arthrex FastThread Interference Screw2Cleared 510(K)
- K200725Citregen Tendon Interference Screw and Citrelock2Cleared 510(K)
- K201749Arthrex SwiveLock Anchor2Cleared 510(K)
- K201786Arthrex Mini Hip PushLock2Cleared 510(K)
- K201414Rotium Bioresorbable Wick2Cleared 510(K)
- K193558HEALICOIL Knotless Suture Anchors2Cleared 510(K)
- K192484Fixone Biocomposite Anchor2Cleared 510(K)
- K192032Fixone Biocomposite Small Anchor2Cleared 510(K)
- K193503Arthrex SwiveLock Suture Anchor2Cleared 510(K)
- K193157Arthrex 3.9mm Corkscrew Suture Anchor2Cleared 510(K)
- K192824Parcus Knotless AP Suture Anchors2Cleared 510(K)
- K192532Arthrex SwiveLock Anchor2Cleared 510(K)
- K192441Arthrex SwiveLock Anchors2Cleared 510(K)
- K191242HEALIX ADVANCE SP BIOCOMPOSITE Anchor2Cleared 510(K)
- K191226Arthrex SwiveLock Suture Anchor2Cleared 510(K)
- K183501Parcus Twist AP Suture Anchors2Cleared 510(K)
- K183236Rotium Bioresorbable Wick2Cleared 510(K)
- K183506HEALIX ADVANCE Anchor with DYNACORD Suture2Cleared 510(K)
- K180768Arthrex SwiveLock Anchors2Cleared 510(K)
- K181746MICRORAPTOR Knotless Suture Anchor2Cleared 510(K)
- K181809GRYPHON® Anchors with DYNACORD™ Suture2Cleared 510(K)
- K180960FIXIT / ComposiTCP Threaded Anchor System2Cleared 510(K)
- K180763CuffLink Implant System Biocomposite2Cleared 510(K)
- K180594Knotless SutureTak Anchors2Cleared 510(K)
- K180361MICRORAPTOR REGENESORB Suture Anchor2Cleared 510(K)
- K180662Arthrex FastThread Interference Screw2Cleared 510(K)
- K180101HEALIX ADVANCE KNOTLESS BR Anchor2Cleared 510(K)
- K173859HEALIX ADVANCE Anchor with DYNACORD Suture2Cleared 510(K)
- K173788Arthrex Corkscrew FT2Cleared 510(K)
- K171228Fiji Anchor2Cleared 510(K)
- K173240Arthrex PushLock2Cleared 510(K)
- K170868FIXIT Threaded Anchor System2Cleared 510(K)
- K171114HEALIX ADVANCE KNOTLESS Anchor2Cleared 510(K)
- K171592CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver2Cleared 510(K)
- K171299Fixone Biocomposite Anchor2Cleared 510(K)
- K170639HEALIX ADVANCE Anchor with PERMATAPE Suture2Cleared 510(K)
- K163672Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor2Cleared 510(K)
- K171141Arthrex SwiveLock Anchors2Cleared 510(K)
- K170501CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver2Cleared 510(K)
- K162429ZipE Knotless Tissue Repair and Attachment Devices2Cleared 510(K)
- K161174Nanova Interference Screw2Cleared 510(K)
- K160804INTRAFIX(TM) Advance Tibial Fastener System2Cleared 510(K)
- K151342Arthrex SwiveLock Anchors2Cleared 510(K)
- K150209Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Bioknotless BR Anchor, Lupine BR Anchor, PanaLok Anchor,PanaLok Anchor with Orthocord, PanaLok RC QuickAnchor Plus; PanaLok RC QuickAnchor Plus Dual Suture, PanaLok RC QuickAnchor Plus w/Orthocord; PanaLok RC QuickAnchor Plus Dual Suture w/Orthocord, PanaLok Loop Anchor, Lupine Loop Anchor, PanaLok RC Lop Anchor, BioKnotless Anchor, BioKnotless RC Anchor, RC Loop Anc2Cleared 510(K)
- K151105Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew Suture Anchors - TAG Bioraptor Suture Anchor 7209317, 7209318, Smith and Nephew Suture Anchors - Bioraptor 2.3 PK Suture Anchor, Smith and Nephew Suture Anchors - Osteoraptor Suture Anchor, Smith and Nephew Suture Anchors - Twinfix Ultra HA Suture Anchor, Smith and Nephew Suture Anchors - OSTEORAPTOR Curved Suture Anchors, Smith and Nephew Suture Anchors - Ultra Fast-Fix Meniscal Repair System, Ultra Fa2Cleared 510(K)
- K143660Milagro / Milagro Advance Interference Screw2Cleared 510(K)
- K143172ACL SMART System2Cleared 510(K)
- K142948BIOSURE REGENESORB interference Screw2Cleared 510(K)
- K140855ARTHREX SUTURETAK SUTURE ANCHORS2Cleared 510(K)
- K140643GRYPHON BR ANCHOR W/PROKNOT TECHNOLOGY,GRYPHON PEEK ANCHOR W/ PROKNOT TECHNOLOGY2Cleared 510(K)
- K141259GRYPHON BR ANCHOR WITH PERMACORD, GRYPHON BR DS ANCHOR WITH PERMACORD,GRYPHON PEEK ANCHOR WITH PERMACORD, GRYPHON PEEK2Cleared 510(K)
- K1337944.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 STRANDS OF #2 PERMACORD SUTURE, 5.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 32Cleared 510(K)
- K132241GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY, GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY - HIP, GRYPHON PEEK ANCHOR W/ PROKNOT T2Cleared 510(K)
- K130716BIORETEC ACTIVASCREW INTERFERENCE2Cleared 510(K)
- K131974HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM)2Cleared 510(K)
- K130917HEALIX ADVANCE KNOTLESS BR ANCHOR2Cleared 510(K)
- K122635TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHOR2Cleared 510(K)
- K123393HEALICOIL SUTURE ANCHOR WITH REGENESORB2Cleared 510(K)
- K122869MILAGRO INTERFERENCE SCREWS2Cleared 510(K)
- K122228LIGAFIX INTERFERENCE SCREW2Cleared 510(K)
- K121890GENESYS PRESSFT SUTURE ANCHOR2Cleared 510(K)
- K120589MILAGRO INTERFERENCE SCREWS2Cleared 510(K)
- K120540BIOBOLT2Cleared 510(K)
- K120078HEALIX ADVANCE BR ANCHOR2Cleared 510(K)
- K113534HEALIX KNOTLESS ANCHOR2Cleared 510(K)
- K112040ARTHREX BIOCOMPOSITE TRANSFIX2Cleared 510(K)
- K112249HEALIX KNOTLESS(TM) ANCHOR2Cleared 510(K)
- K103831DEPUY MITEK MILAGRO INTERFERENCE SCREW MODEL 231803, 231804, 231807, 2318092Cleared 510(K)
- K110660ARTHREX BIOCOMPOSITE SUTURETAK2Cleared 510(K)
- K103309OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS2Cleared 510(K)
- K101459OSTEORAPTOR II SUTURE ANCHOR OR TO BE DETERMINED MODEL: 72202764 72202765 72202766 72202767 72202768 72202769 722027702Cleared 510(K)
- K101823ARTHREX SWIVELOCK ANCHORS2Cleared 510(K)
- K102982ENDOBUTTON DIRECT2Cleared 510(K)
- K101679ARTHREX PUSHLOCK ANCHORS2Cleared 510(K)
- K101100CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-65032Cleared 510(K)
- K100012GRYPHON T BR DS ANCHOR W/ORTHOCORD, GRYPHON T BR ANCHOR W /ORTHOCORD, GRYPHON P BR DS ANCHOR W/ORTHOCORD, GRYPHON P BR A2Cleared 510(K)
- K093844SMITH & NEPHEW TWINFIX ULTRA HA SUTURE ANCHOR2Cleared 510(K)
- K092898CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES2Cleared 510(K)
- K091844ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS2Cleared 510(K)
- K091041RIGIDFIX BIOCRYL 2.7MM BTB (210815), FEMORAL 3.3MM ST (210816), AND TIBIAL 3.3MM ST (210817) CROSS PIN KITS2Cleared 510(K)
- K090835CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CR2Cleared 510(K)
- K090186CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES2Cleared 510(K)
- K090669RIGIDFIX BIOCRYL CROSS PIN KITS2Cleared 510(K)
- K090124GRYPHON P BR DS ANCHOR W/ORTHOCORD,GRYPHON P BR ANCHOR W/ORTHOCORD, MODEL 210813,2108142Cleared 510(K)
- K083268TORNIER, INC., INSITE SUTURE ANCHORS2Cleared 510(K)
- K082810ARTHREX BIO-COMPOSITE SUTURE ANCHORS: ARTHREX BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK AND BIO-COMPOSITE CORKSCREW2Cleared 510(K)
- K082999ARTHREX MENISCAL DART, ARTHREX MENISCAL DARTSTICK, ARTHREX CHONDRAL DART2Cleared 510(K)
- K073412GRYPHON BR AND HEALIX BR ANCHORS2Cleared 510(K)
- K071456ARTHREX PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANT2Cleared 510(K)
- K071176MODIFICATION TO: ARTHREX INTERFERENCE SCREW2Cleared 510(K)
- K070925MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR2Cleared 510(K)
- K070178AESCULAP RESORBABLE PIN, MODEL FR7352Cleared 510(K)
- K053492BIODUCT2Cleared 510(K)
- K063497MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM2Cleared 510(K)
- K062466ARTHREX INTERFERENCE SCREW2Cleared 510(K)
- K062782INION ANCHRON PLUS BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-60012Cleared 510(K)
- K060522SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM2Cleared 510(K)
- K052799MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEM2Cleared 510(K)
- K051983MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR2Cleared 510(K)
- K051362INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-60002Cleared 510(K)
- K051219PUSHLOCK2Cleared 510(K)
- K051250AXYA, MODEL 6500 AXYALOOP BIO-ABSORBABLE BONE ANCHOR2Cleared 510(K)
- K042966DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCHOR, MODELS BXS4218, BXS4218H2Cleared 510(K)
- K041698AXYA MEDICAL, INC. MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR2Cleared 510(K)
- K041128SUTURE ARROW2Cleared 510(K)
- K041307MODIFICATION TO STRYKER XCEL ANCHOR SYSTEM2Cleared 510(K)
- K041305STRYKER BIOZIP SUTURE ANCHOR SYSTEM2Cleared 510(K)
- K040827PANALOK LOOP ANCHOR2Cleared 510(K)
- K032197TWIN FIX AB 6.5 MM SUTURE ANCHOR, MODELS 720209, 7210210, 7210211, 72102122Cleared 510(K)
- K0319812.4 SMARTNAIL, MODELS 532416, 532425, 532435, 5324452Cleared 510(K)
- K031519CUFFLOK ANCHOR2Cleared 510(K)
- K011985SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT2Cleared 510(K)
- K012465MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR2Cleared 510(K)
- K013057BIOCUFF,C, MODELS 236018, 236028, 2360362Cleared 510(K)
- K012334CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 5411162Cleared 510(K)
- K011495ARTHREX BIO-POST AND WASHER2Cleared 510(K)
- K011299SMITH AND NEPHEW 5.00MM ABSORBABLE POLYMER ANCHOR2Cleared 510(K)
- K003984SUPER REVO SUTURE ANCHOR2Cleared 510(K)
- K002406MITEK 2GII MENISCAL REPAIR SYSTEM2Cleared 510(K)
- K003743SYNTHES MODIFIED BIORESORBABLE SUTURE ANCHOR SYSTEM2Cleared 510(K)
- K003970CONTOUR LABRAL NAIL, MODEL 533520A2Cleared 510(K)
- K003273LACTOSORB SCREW ANCHOR2Cleared 510(K)
- K003227BIO-ABSORBABLE CORKSCREW MODEL AR-1920B2Cleared 510(K)
- K003076MITEK CUFFTACK2Cleared 510(K)
- K002413ULTRASORB SUTURE ANCHOR2Cleared 510(K)
- K002020LACTOSORB MENISCAL SCREW2Cleared 510(K)
- K001378BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 2357362Cleared 510(K)
- K994161SYNTHES BIORESORBABLE SUTURE ANCHOR2Cleared 510(K)
- K000506BIO-FASTAK SUTURE ANCHOR, MODEL AR-1324B2Cleared 510(K)
- K000616SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 4308282Cleared 510(K)
- K990340ARTHREX PLA TISSUETAK, MODEL # AR-1940 BU2Cleared 510(K)
- K990987BIO-ABSORBABLE CORKSCREW, MODEL AR-1920B2Cleared 510(K)
- K994269TITAN RC TACK2Cleared 510(K)
- K993115MULTITAK SS2Cleared 510(K)
- K993339ENDOPEARL WITH THREADER2Cleared 510(K)
- K993074SMART NAIL MODELS 521516, 521520,521525, 531516, 531520. 5315252Cleared 510(K)
- K993073SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 2390302Cleared 510(K)
- K993061STRYKER LEIBINGER RESORBABLE FIXATION SYSTEM2Cleared 510(K)
- K993453MENISCUS ARROW, MODELS 531110, 531113, 5311162Cleared 510(K)
- K993373ROTORBLADE SUTURE ANCHOR2Cleared 510(K)
- K992938ROTORBLADE SUTURE ANCHOR2Cleared 510(K)
- K992567ANATOMICAL BANKART TACK, MODEL 523520A2Cleared 510(K)
- K983577ARTHREX MENISCAL DART SYSTEM2Cleared 510(K)
- K991715BIOSTINGER-V BIOABSORBABLE MENISCAL REPAIR DEVICE2Cleared 510(K)
- K991009RC BUTTRESS2Cleared 510(K)
- K984171ENDOPEARL2Cleared 510(K)
- K983435ROTORBLADE2Cleared 510(K)
- K990999MODIFICATION OF: EBI SPINELINK SYSTEM2Cleared 510(K)
- K990361HEADED BIO-ABSORBABLE CORKSCREW MODEL #AR-1921BU2Cleared 510(K)
- K983843BIO-BUTTON 6.5MM, BIO-BUTTON 8MM, MODEL #'S AR-2236B & AR-2238B2Cleared 510(K)
- K984490SUTURELESS ANCHOR2Cleared 510(K)
- K982095LACTOSORB MENISCAL REPAIR DEVICE2Cleared 510(K)
- K983186BIO-ANCHOR, PRE-LOADED BIOABSORBABLE SUTURE ANCHOR2Cleared 510(K)
- K982900PHANTOM SOFTHREAD SOFT TISSUE INTERFERENCE SCREW2Cleared 510(K)
- K981340INNOVASIVE DEVICES MENISCAL DART REPAIR SYSTEM2Cleared 510(K)
- K972783BIOFIX BIODEGRADABLE THREADED SUTURE ANCHOR2Cleared 510(K)
- K974876BIONX DISTAL RADIUS SCREW2Cleared 510(K)
- K973381BIOROC EZ SUTURE BONE FASTENER2Cleared 510(K)
- K973849BIOABSORBABLE BANKART TACK2Cleared 510(K)
- K965228FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUE2Cleared 510(K)
- K973281THE SURGICAL DYNAMICS* S.D. SORB* E-Z TAC*2Cleared 510(K)
- K971358BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MM2Cleared 510(K)
- K970896MITEK 3.5 MM PANALOK WEDGE ABSORBABLE SUTURE ANCHOR SYSTEM2Cleared 510(K)
- K964805BIO-ANCHOR2Cleared 510(K)
- K963369BIO-ANCHOR2Cleared 510(K)
- K963396BIOSPHERE SUTURE ANCHOR2Cleared 510(K)
- K964013MITEK ABSORBABLE TOGGLE ANCHOR2Cleared 510(K)
- K964521DEPUY DUPONT PHANTOM SUTURE ANCHOR2Cleared 510(K)
- K961789RESORBABLE SOFT TISSUE ATTACHMENT DEVICE2Cleared 510(K)
- K960555BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR2Cleared 510(K)
- K955768BIOFIX BIODEGRADABLE MENISCUS ARROW SYSTEM2Cleared 510(K)
- K955486BIO-ANCHOR2Cleared 510(K)
- K952687PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEM2Cleared 510(K)
- K955003BIOFIX BIODEGRADABLE SELF-REINFORCED POLY-L-LACTIDE (SR-PLLA) MINI-TACK2Cleared 510(K)
- K944544ABSORBABLE BONE SCREW2Cleared 510(K)
- K950275RESORBABLE SOFT TISSUE ATTACHMENT DEVICE2Cleared 510(K)
- K952471BIOFIX BIOABSORABABLE SELF-REINFORCED POLY-L-LACTIDE, THREADED FIXATION ROD2Cleared 510(K)
- K943249BIOABSORBABLE INTERFERENCE SCREW2Cleared 510(K)
- K933948ACUFEX ENDOBUTTON SYSTEM2Cleared 510(K)
- 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
- 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
OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K212912
- 510(k) Type
- Traditional
- Applicant
- b-ONE ORTHO, Corp
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/4/2021
- Days to Decision
- 52 days
- Submission Type
- Summary