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
- K252657Impact PEEK Union Nail System2Cleared 510(K)
- K250315RONAVIS – FX (FX-001)2Cleared 510(K)
- K251362PediFlex™ Flexible Nail System2Cleared 510(K)
- K250646Impact PEEK Union Nail System2Cleared 510(K)
- K241014Biomet Kirschner Wires (K-Wires)2Cleared 510(K)
- K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail2Cleared 510(K)
- K231147Hammerdesis™ Interphalangeal Fusion System2Cleared 510(K)
- K230750OSSIOfiber® Cannulated Trimmable Fixation Nail2Cleared 510(K)
- K231905Electro-Spec Steri-Caps2Cleared 510(K)
- K231339Tyber Medical Pin and Wire System (various)2Cleared 510(K)
- K221283Hammertoe Truss System (HTS)2Cleared 510(K)
- K220906SECURE-LOCK2Cleared 510(K)
- K213982Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires2Cleared 510(K)
- K211789restor3d Pin Implants2Cleared 510(K)
- K211439Small Bone Nailing System2Cleared 510(K)
- K203698CoLink Sfx Implant System2Cleared 510(K)
- K203475LimaCorporate Kirschner Wire2Cleared 510(K)
- K201838PediFlex Flexible Nail System2Cleared 510(K)
- K203465OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design2Cleared 510(K)
- K202777VeriFixx™ Small Bone Implant2Cleared 510(K)
- K201803OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant2Cleared 510(K)
- K201715Smart Toe II, X Fuse2Cleared 510(K)
- K200068Arthrex DynaNite K-Wire2Cleared 510(K)
- K190652OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant2Cleared 510(K)
- K190926Hammertoe Truss System (HTS)2Cleared 510(K)
- K190287Arthrex DynaNite® PIP (Hammertoe) Implant2Cleared 510(K)
- K183228HammerToe Compression System2Cleared 510(K)
- K181180OSSIO™ Pin Product Family2Cleared 510(K)
- K180087A.M. Surgical Intramedullary Fixation Device2Cleared 510(K)
- K171715HammerTube System2Cleared 510(K)
- K172485Footmotion HammerToe2Cleared 510(K)
- K173616DIP Arthrodesis System2Cleared 510(K)
- K173013WishBone K-Wire System2Cleared 510(K)
- K173051Orthofix MJ-FLEX THE NEW METAIZEAU NAIL2Cleared 510(K)
- K170326dynaMX Intramedullary Implant2Cleared 510(K)
- K170418Stryker SonicPin System2Cleared 510(K)
- K163327Precifit Medical Kirschner Wires2Cleared 510(K)
- K161489Syntorr K-wire and Pin System2Cleared 510(K)
- K160264Additive Orthopaedics Hammertoe Correction System2Cleared 510(K)
- K160194StarFuse Interphalangeal Pin2Cleared 510(K)
- K152662S-Wire2Cleared 510(K)
- K153204In2Bones Kirschner wire2Cleared 510(K)
- K152627IFS Fixation Scaffold System2Cleared 510(K)
- K151876Bio2 Fusion Implant System2Cleared 510(K)
- K142478opti-Toe2Cleared 510(K)
- K150626Rush Medullary Pins2Cleared 510(K)
- K150416ProCinch Adjustable Loop Device2Cleared 510(K)
- K143702Arthrex Blunt Tip Screws with Fiber Tape2Cleared 510(K)
- K143049LYNC intramedullary implant2Cleared 510(K)
- K143618Kirschner Wires, Steinmann Pins2Cleared 510(K)
- K143063Stryker SonicPin System, Stryker SonicAnchor System2Cleared 510(K)
- K141714PRO-TOE X-FLEX HAMMERTOE FIXATION SYSTEM2Cleared 510(K)
- K142134C-WIRE DOUBLE ENDED ORTHOPEDIC WIRES2Cleared 510(K)
- K141004INTRAOSSEOUS FIXATION SYSTEM2Cleared 510(K)
- K141577ARTHREX PIP DART2Cleared 510(K)
- K133932INION FREEDOMPIN2Cleared 510(K)
- K133477TOEGRIP, IMPLANT FOR PROXIMAL INTER-PHALANGEAL ARTHRODESIS2Cleared 510(K)
- K133950ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.)2Cleared 510(K)
- K133520HAMMERLOCK 22Cleared 510(K)
- K132895WMT IMPLANTABLE K-WIRE2Cleared 510(K)
- K131640SMOOTH OR THREADED METALLIC BONE FASTENER2Cleared 510(K)
- K130105RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS PIN SYSTEM2Cleared 510(K)
- K122415X-FIX DYNAMIC EXTERNAL DISTRACTOR2Cleared 510(K)
- K121008TRILLIANT SURGICAL K-WIRES2Cleared 510(K)
- K121004APEX KIRSCHNER WIRES AND STEINMANN PINS2Cleared 510(K)
- K120165INTRAOSSEOUS FIXATION SYSTEM2Cleared 510(K)
- K103623NEWDEAL INTERPHALANGEAL IMPLANT2Cleared 510(K)
- K112990ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE2Cleared 510(K)
- K112675ARROW-LOK DIGITAL SYSTEM2Cleared 510(K)
- K112197MEMOMETAL INTRA-MEDULLARY BONE FASTENER2Cleared 510(K)
- K112254APEX KIRSCHNER WIRES AND STEINMANN PINS2Cleared 510(K)
- K110123PCL TIGHTROPE2Cleared 510(K)
- K110047VERTICOR K-WIRE SYSTEM2Cleared 510(K)
- K101837ACL TIGHTROPE DOUBLE BUNDLE2Cleared 510(K)
- K102215KIRSCHNER WIRES, STEINMAN PINS2Cleared 510(K)
- K102072MEMOMETAL IMPLANTS (K-SNAP & TI-FUSE)2Cleared 510(K)
- K100926ARROWHEAD FIXATION DEVICE2Cleared 510(K)
- K100736KIRSCHNER AND GUIDE WIRES2Cleared 510(K)
- K094043LIGAMENTOTAXOR2Cleared 510(K)
- K100652ACL TIGHTROPE2Cleared 510(K)
- K091955STRYKER SONICPIN SYSTEM2Cleared 510(K)
- K091951HAMMERLOCK2Cleared 510(K)
- K092038APTUS K-WIRE SYSTEM2Cleared 510(K)
- K083490BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-186852Cleared 510(K)
- K082375ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM2Cleared 510(K)
- K082017STARR FRAME STEINMANN PIN2Cleared 510(K)
- K080879ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM2Cleared 510(K)
- K081097ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM2Cleared 510(K)
- K073311OSTEOTRANS-OT PIN2Cleared 510(K)
- K073674BONE FIXATION WIRE (KIRSCHNER WIRE)2Cleared 510(K)
- K071616ARC SURGICAL BIOTRAK PIN SYSTEM2Cleared 510(K)
- K071863ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS)2Cleared 510(K)
- K070598MEMOMETAL INTRA-MEDULLARY BONE FASTENER, MODELS SMART TOE / X-FUSE2Cleared 510(K)
- K070555ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRES2Cleared 510(K)
- K070561KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES2Cleared 510(K)
- K063719ARTHREX CROSSPIN, MODEL AR-1964P2Cleared 510(K)
- K061607STORM OPERATING KIT, MODEL 1-10-02Cleared 510(K)
- K061164ACTIVAPIN2Cleared 510(K)
- K060654DSI PINS AND WIRES2Cleared 510(K)
- K060283TRANSET SYSTEM2Cleared 510(K)
- K052736ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-899XT2Cleared 510(K)
- K051605SBI K-WIRES2Cleared 510(K)
- K050259ARTHREX BIO-PIN2Cleared 510(K)
- K043339REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L; (PLGA), MODELS 2070LG, 2770LG, 3570LG, 4570LG2Cleared 510(K)
- K050275MODIFICATION TO: INION OTPS BIODEGRADABLE PIN2Cleared 510(K)
- K043106PINN-ACL CROSSPIN2Cleared 510(K)
- K041355HUMERAL STAPLE2Cleared 510(K)
- K041157MODIFICATION TO SMALL BONE FIXATION SYSTEM2Cleared 510(K)
- K041288MODIFICATION TO SMARTPIN2Cleared 510(K)
- K040500ARTHROTEK LACTONAIL2Cleared 510(K)
- K033717TRANSET FRACTURE FIXATION SYSTEM2Cleared 510(K)
- K033968HANSSON PIN SYSTEM2Cleared 510(K)
- K033406SMALL BONE FIXATION SYSTEM2Cleared 510(K)
- K024185BIODHOC2Cleared 510(K)
- K032687ACE NANCY NAIL2Cleared 510(K)
- K031712INION OTPS BIODEGRADABLE PIN2Cleared 510(K)
- K031083OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-15002Cleared 510(K)
- K030665BONE WIRE2Cleared 510(K)
- K022597K-FIX2Cleared 510(K)
- K022599NEWDEAL K WIRE2Cleared 510(K)
- K0225312MM PEDIATRIC FLEX NAIL2Cleared 510(K)
- K013888FIXATION (STEINMANN) PINS2Cleared 510(K)
- K014305RESORBABLE LACTOSORB-L ACL CROSSPIN2Cleared 510(K)
- K013781RIDIDFIX 2.7MM BTB CROSS PIN KIT2Cleared 510(K)
- K013424INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND2Cleared 510(K)
- K012125OPUS MAGNUM ANCHOR & INSERTER2Cleared 510(K)
- K012161FLEX-NAILS2Cleared 510(K)
- K011522RESORBABLE BONE PINS2Cleared 510(K)
- K010983PLLA PIN2Cleared 510(K)
- K010479MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR2Cleared 510(K)
- K003527MODIFICATION TO SYNTHES (USA) POLYPIN2Cleared 510(K)
- K003659PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,1732602Cleared 510(K)
- K002125PINS AND WIRES2Cleared 510(K)
- K991971ARTHREX CHONDRAL DART, MODEL AR-4005B-182Cleared 510(K)
- K994232PHALANGEAL FIXATION SYSTEM2Cleared 510(K)
- K991064METACARPAL FIXATION SYSTEM2Cleared 510(K)
- K990291LACTOSORB BONE PIN2Cleared 510(K)
- K983121NON-STERILE KIRSCHNER WIRES AND STEINMANN PINS, MODELS #'S 290-101/160, 290-201/216, 290-060/330, 290-161/2202Cleared 510(K)
- K982719THE BONE TIE2Cleared 510(K)
- K980854RETROGRADE PEDIATRIC NAIL2Cleared 510(K)
- K974341MITEK BTB ABSORBABLE (PLA) CROSS PIN2Cleared 510(K)
- K974291MITEK BTB ABSORBABLE (PLA) CROSS PIN2Cleared 510(K)
- K973240SYNTHES PROXIMAL FEMORAL NAIL(PFN) SYSTEM MODIFICATION2Cleared 510(K)
- K971962OSTEO KIRSCHNER WIRES2Cleared 510(K)
- K971783SYNTHES ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM2Cleared 510(K)
- K971453ORTHOTEC K-CAP SYSTEM2Cleared 510(K)
- K961608SYNTHES (U.S.A.) POLYPIN2Cleared 510(K)
- K970733SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEM2Cleared 510(K)
- K970036FIXATION PIN OR ROD2Cleared 510(K)
- K970013BIORIGID NAIL TIBIA2Cleared 510(K)
- K964500ACUMED TENSION BAND PIN2Cleared 510(K)
- K964087BLOCK STOP WIRES2Cleared 510(K)
- K963367RMS K-WIRE2Cleared 510(K)
- K961522KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN2Cleared 510(K)
- K960642NANCY NAIL2Cleared 510(K)
- K960482K-WIRE2Cleared 510(K)
- K960483STEINMAN PIN2Cleared 510(K)
- K960385STERILE KIRSCHNER WIRES AND STEINMANN PINS2Cleared 510(K)
- K955806HOWMEDICA BIOABSORBABLE PIN2Cleared 510(K)
- K954543GO UNIVERSALK-WIRE FLUTED DRILL2Cleared 510(K)
- K953194LACTOSORB BONE PIN2Cleared 510(K)
- K954001SPETZLER PIN2Cleared 510(K)
- K943856FIXATION PINS/WIRES2Cleared 510(K)
- K945639SPETZLER PIN2Cleared 510(K)
- K940666JBS SMOOTH FIXATION PIN2Cleared 510(K)
- K940673J.B.S. SELF-TAPPING THREADED PIN2Cleared 510(K)
- K940669J.B.S. B.A.C. PIN2Cleared 510(K)
- K941434K-WIRES AND STEINMANN PINS2Cleared 510(K)
- K925098BIOFIX ABSORBABLE SELF-REINFORCED POLY-L-LACTIDE2Cleared 510(K)
- K931836ACUFEX SMOOTH AND THREADED PINS2Cleared 510(K)
- K931697FIXATION PIN2Cleared 510(K)
- K930969BAUMER PINS2Cleared 510(K)
- K932348ORTHOPEDIC SMOOTH PIN FIXATION2Cleared 510(K)
- K940109TAVA K-WIRE2Cleared 510(K)
- K922766ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION2Cleared 510(K)
- K925301OTI ORTHOPEDIC FASTENER SYSTEM2Cleared 510(K)
- K922194OSTEO STEINMANN PIN2Cleared 510(K)
- K922193OSTEO KIRSCHNER WIRE2Cleared 510(K)
- K911375G-PIN2Cleared 510(K)
- K911505FIXATION WIRE2Cleared 510(K)
- K911452FIXATION PIN2Cleared 510(K)
- K905337STEINMAN PIN2Cleared 510(K)
- K905345K-WIRE2Cleared 510(K)
- K905341RUSH PIN2Cleared 510(K)
- K903264K-WIRE2Cleared 510(K)
- K903265STEINMAN PIN2Cleared 510(K)
- K901273L.M.S. SELF-DETACHABLE BROACH WITH STOP2Cleared 510(K)
- K890902BIOFIX* BIODEGRADABLE FIXATION ROD2Cleared 510(K)
- K895079ACE BEADED K-WIRES ACE OLIVE WIRES2Cleared 510(K)
- K874913ORTHOMET PIN SYSTEM2Cleared 510(K)
- K872842PIN, HIP, KNOWLES2Cleared 510(K)
- K864912PDS (POLYDIOXANON) ABSORBABLE PIN2Cleared 510(K)
- K863734STEINMANN(THREADED/CALIBRATED),KNOWLES&HOGIE PINS2Cleared 510(K)
- K863119CANNULATED LAG SCREWS2Cleared 510(K)
- K860590ACE UNILATERAL FIXATOR2Cleared 510(K)
- K852560PINSET, BONE, RUSH 9-1/2 THRU 20-3/4 INCHES LONG2Cleared 510(K)
- K852561PIN SET, BONEM, RUSH, 1 THRU 10 INCHES LONG2Cleared 510(K)
- K852562PIN SET, BONE, RUSH, 4 THRU 10 1/2 INCHES LONG2Cleared 510(K)
- K852563PIN SET, BONE RUSH, 7-1/4 THRU 18-1/2 INCHES LONG2Cleared 510(K)
- K850026ORTHOPEDIC IMPLANT NAILS & PINS2Cleared 510(K)
- K833952FIXATION PINS2Cleared 510(K)
- K831005WIRE & STEINMAN PINS2Cleared 510(K)
- K771418PIN RETRACTORS2Cleared 510(K)
- 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
- 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
Bio2 Fusion Implant System
- Page Type
- Cleared 510(K)
- 510(k) Number
- K151876
- 510(k) Type
- Traditional
- Applicant
- Bio2 Technologies, Inc
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/30/2015
- Days to Decision
- 174 days
- Submission Type
- Summary