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
- K243798Orthex External Fixation System2Cleared 510(K)
- K241563Extremity Medical External Fixation System2Cleared 510(K)
- K242861TrueLok Elevate2Cleared 510(K)
- K242452Monkey Bars Pin to Bar External Fixation System2Cleared 510(K)
- K241769Response Ortho Metaphyseal Hinge Fixator System2Cleared 510(K)
- K233025Revolution External Plating System2Cleared 510(K)
- K240049LINK(TM) External Fixator2Cleared 510(K)
- K233741Hoffmann LRF System2Cleared 510(K)
- K221787Auxein's DHS/DCS Plate System2Cleared 510(K)
- K232897Arthrex Small External Fixation System2Cleared 510(K)
- K232838Monkey RingsTM External Fixation System2Cleared 510(K)
- K231922DEPUY SYNTHES MAXFRAME AUTOSTRUT System2Cleared 510(K)
- K231461Smart Correction System (HA Half Pins)2Cleared 510(K)
- K223786Orthex External Fixation System2Cleared 510(K)
- K213905ONX Large External Fixation System2Cleared 510(K)
- K221366Smart Correction System Rings and Compatible HA-Coated Half Pins2Cleared 510(K)
- K220809Drive Rail System2Cleared 510(K)
- K212895Paragon 28 External Ring Fixation System2Cleared 510(K)
- K212044TrueLok Evo2Cleared 510(K)
- K212552Correx Software2Cleared 510(K)
- K210953SMART Taylor Spatial Frame2Cleared 510(K)
- K211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)2Cleared 510(K)
- K211112OIC External Fixation System2Cleared 510(K)
- K203568Hoffmann LRF System2Cleared 510(K)
- K202833Sequel External Fixation Device2Cleared 510(K)
- K202810AutoStrut G22Cleared 510(K)
- K200491Bfix Orthopedic External Fixator Systems2Cleared 510(K)
- K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation2Cleared 510(K)
- K202762Circular Fixation with Balanced Cable Transport2Cleared 510(K)
- K200728Pitkar DeftFix System2Cleared 510(K)
- K200123Accessories for the SixFix® Hexapod Fixator2Cleared 510(K)
- K193368Smart Correction System2Cleared 510(K)
- K200343FusionFrame Ring Lock System2Cleared 510(K)
- K202143Dynex Micro2Cleared 510(K)
- K202054Dynex Ring Fixation System, Diametrix Ring Fixation System2Cleared 510(K)
- K200518Pitkar External Fixation System - Rail Mechanism2Cleared 510(K)
- K192181PRECICE Plating System2Cleared 510(K)
- K190486Pitkar External Fixation System2Cleared 510(K)
- K191241AutoStrut2Cleared 510(K)
- K181630Revolution External Plating System2Cleared 510(K)
- K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)2Cleared 510(K)
- K183682OIC External Fixation System2Cleared 510(K)
- K181528Austin Miller Large External Fixation System2Cleared 510(K)
- K182968Hoffmann LRF System2Cleared 510(K)
- K182154Depuy Synthes Femoral Neck System2Cleared 510(K)
- K173883External Fixation System2Cleared 510(K)
- K180580Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices2Cleared 510(K)
- K180832SALVATION External Fixation System2Cleared 510(K)
- K172872DePuy Synthes Femoral Neck System2Cleared 510(K)
- K172438ARBOR External Fixation System2Cleared 510(K)
- K171911Medline ReNewal Reprocessed Synthes External Fixation Systems2Cleared 510(K)
- K170146Galaxy UNYCO System2Cleared 510(K)
- K171211OIC External Fixation System2Cleared 510(K)
- K170482Spider Frame External Fixation System2Cleared 510(K)
- K170704The Locking Pediatric Osteotomy Plate (LolliPOP) System2Cleared 510(K)
- K163486DRACO Locking Bone Screws; DRACO Compression Screws; DRACO MetaFuse L Plates; DRACO MetaFuse BLP Plates; DRACO MetaFuse MTP Plates, Takú Plates, DuoTakú Plates, Open Wedge Plates, Osteoplate Plates, Plantar Plates, Calcaneus Offset Locking Plates2Cleared 510(K)
- K170650Orthofix TrueLok Hexapod System (TL-HEX) V2.02Cleared 510(K)
- K163656Hoffmann LRF System2Cleared 510(K)
- K163323Dolphix® External Fixation System MR Conditional2Cleared 510(K)
- K162033SALVATION External Fixation System2Cleared 510(K)
- K162032Arrowhead Mini-Rail Fixator2Cleared 510(K)
- K160972Gexfix External Fixation2Cleared 510(K)
- K161753Hoffman LRF System2Cleared 510(K)
- K161417DePuy Synthes MAXFRAME Multi-Axial Correction System2Cleared 510(K)
- K160830Integra External Fixation System2Cleared 510(K)
- K153377Hoffmann LRF (Limb Reconstruction Frame) System2Cleared 510(K)
- K151881X-Fix Line Additions2Cleared 510(K)
- K151580D.N.E. External Fixation System2Cleared 510(K)
- K153635SALVATION(R) External Fixation System2Cleared 510(K)
- K153415Reprocessed Stryker External Fixation Devices2Cleared 510(K)
- K153233Galaxy UNYCO System2Cleared 510(K)
- K151907Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables2Cleared 510(K)
- K152755FastFrame External Fixation System-Ankle Spanning2Cleared 510(K)
- K152484FastFrame External Fixation System - Distal Radius2Cleared 510(K)
- K150640RX-FIX Mini Rail External Fixator2Cleared 510(K)
- K151992FastFrame External Fixation System - Knee Spanning, FastFrame External Fixation System - Damage Control2Cleared 510(K)
- K152171Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.42Cleared 510(K)
- K152158ARIX Ankle System2Cleared 510(K)
- K152045SALVATION® External Fixation System2Cleared 510(K)
- K150818Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System2Cleared 510(K)
- K150579Cardinal Health External Fixation System2Cleared 510(K)
- K150004SALVATION External Fixation System2Cleared 510(K)
- K143220SIDEKICK EZ FRAME External Fixation System2Cleared 510(K)
- K143125Orthofix True Lok Hexapod System VI.32Cleared 510(K)
- K141760ORTHOFIX GALAXY WRIST2Cleared 510(K)
- K142052ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT2Cleared 510(K)
- K142520Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software2Cleared 510(K)
- K140961HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM2Cleared 510(K)
- K141912AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BON2Cleared 510(K)
- K140463INTEGRA EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K141697XTRAFIX EXTERNAL FIXATION SYSTEM, XTRAFIX SMALL EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K141078ORTHOFIX TL-HEX TRUE LOK HEXALOBE SYSTEM (TL-HEX)2Cleared 510(K)
- K140675EMERGE EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K140822DRIVE RAIL SYSTEM2Cleared 510(K)
- K140158S.E.A.L. FRACTURE FUSION TUBE2Cleared 510(K)
- K131413XTRAFIX SMALL EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K132363DOLPHIX EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K130907HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM2Cleared 510(K)
- K122777NBX - NON BRIDGING EXTERNAL FIXATOR HAND2Cleared 510(K)
- K130479ILIZAROV DRILL TIP WIRES2Cleared 510(K)
- K130334HOFFMANN LRF (LIMB RECONSTRUCTION FRAME SYSTEM)2Cleared 510(K)
- K122210NEWFIX EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K122455SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K130044SIDEKICK EZ FRAME EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K122284HOFFMANN 32Cleared 510(K)
- K113770ORTHOFIX GALAXY FIXATION SYSTEM2Cleared 510(K)
- K121252HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K113383XTRAFIX EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K113384EXTERNAL FIXATOR ST.A R 90 F42Cleared 510(K)
- K113327HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM2Cleared 510(K)
- K111786HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K113123OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEM2Cleared 510(K)
- K113106DNE EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K112218ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS2Cleared 510(K)
- K110426DYNA-EXTOR II2Cleared 510(K)
- K111993FRAMEWALKER2Cleared 510(K)
- K111155XTRAFIX EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K111376CONSTRUX EXTERNAL FIXATION DEVICE2Cleared 510(K)
- K110965RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K102843MAC MALE ADAPTER2Cleared 510(K)
- K103015ODRC-DYNAMIC HIP SCREW SYSTEM2Cleared 510(K)
- K101338NEWFIX EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K110069SMITH & NEPHEW, INC SPATIALFRAME V4.1 WEB-BASED SOFTWARE2Cleared 510(K)
- K102057TARGON FN SYSTEM2Cleared 510(K)
- K102688MERETE LOCKING BONE PLATE SYSTEM II2Cleared 510(K)
- K101759QUANTUM RING FIXATION SYSTEM MODEL ISF2Cleared 510(K)
- K093047SMITH & NEPHEW CIRCULAR FIXATION SYSTEM2Cleared 510(K)
- K101170ACUTE INNOVATIONS STERNAL FIXATION SYSTEM2Cleared 510(K)
- K100795JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING2Cleared 510(K)
- K093753MDPO FRAME SYSTEM2Cleared 510(K)
- K100137SIDEKICK CIRCULAR FIXATOR SYSTEM: STRUTS AND HINGES2Cleared 510(K)
- K100857FUSION MEDICAL RING LOCK SYSTEM2Cleared 510(K)
- K092190SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS2Cleared 510(K)
- K090658SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL2Cleared 510(K)
- K093550MINI RAIL EXTERNAL FIXATOR SYSTEM2Cleared 510(K)
- K092002AFGHAN EXTERNAL FIXATOR2Cleared 510(K)
- K093057BIOMET VISION FOOTRING SYSTEM2Cleared 510(K)
- K092834HOFFMAN XPRESS LINE EXTENSION2Cleared 510(K)
- K091619ANGLEFIX T LOCKING PLATE, MODELS AF-001 (PLATE), ST-1 (LOCKING SCREW)2Cleared 510(K)
- K083582SIGN HIP CONSTRUCT (SHC), MODEL: 7012Cleared 510(K)
- K091258EXTRAFIX EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K090926SMITH & NEPHEW RAIL SYSTEM2Cleared 510(K)
- K090063MERETE LOCKING BONE PLATE SYSTEM2Cleared 510(K)
- K083789ACE FISCHER EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K083636REPROCESSED EXTERNAL FIXATION DEVICE2Cleared 510(K)
- K082833NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER2Cleared 510(K)
- K082650SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL2Cleared 510(K)
- K081586REPROCESSED EXTERNAL FIXATION DEVICE2Cleared 510(K)
- K081342REPROCESSED EXTERNAL FIXATION ACCESSORIES2Cleared 510(K)
- K081244LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS2Cleared 510(K)
- K081284VARIAX DISTAL FIBULA PLATE2Cleared 510(K)
- K081278OMEGA 3 TROCHANTERIC STABILIZING PLATE2Cleared 510(K)
- K080408EXTERNAL FIXATION CLAMP 5.0 MM PIN X9.5MM ROD, MODEL 1151-100, EXTERNAL FIXATON CLAMP, 9.5MM ROD2Cleared 510(K)
- K072212JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE2Cleared 510(K)
- K073076HOFFMANN LIGHT SYSTEM2Cleared 510(K)
- K073527VARIAX ELBOW SYSTEM2Cleared 510(K)
- K080071SIDEKICK RAIL FIXATOR2Cleared 510(K)
- K072250SUPERCABLE GRIP AND PLATE SYSTEM2Cleared 510(K)
- K071852AAP APS SYSTEM2Cleared 510(K)
- K071395BIOMET VISION FOOTRING SYSTEM2Cleared 510(K)
- K071394MODIFICATION TO:SBI RINGFIX2Cleared 510(K)
- K070724IOS EXTERNAL FIXATOR, MODEL 2-0-02Cleared 510(K)
- K070454OMEGA 3 SUPRACONDYLAR PLATE2Cleared 510(K)
- K070016BLUE SHARK2Cleared 510(K)
- K063487MERETE BLP SMALL FRAGMENT LOCKING BONE PLATE2Cleared 510(K)
- K063509DEPUY PEAK FX HIP PLATE2Cleared 510(K)
- K063551AEQUALIS HUMERAL PLATE2Cleared 510(K)
- K061759REPROCESSED EXTERNAL FIXATION DEVICE2Cleared 510(K)
- K062066OMEGA 3 SYSTEM2Cleared 510(K)
- K061748FRAGMENT PLATE SYSTEM2Cleared 510(K)
- K060613VARIAX LOCKING PLATE SYSTEM2Cleared 510(K)
- K060545UNITY HUMERAL PLATE2Cleared 510(K)
- K052918REPROCESSED EXTERNAL FIXATION DEVICES2Cleared 510(K)
- K053472HOFFMANN II MRI EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K053051VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES2Cleared 510(K)
- K053349HOFFMANN II ROD TO WIRE COUPLING2Cleared 510(K)
- K053038HOFFMANN II COMPACT MRI EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K052196VILEX X-FIX2Cleared 510(K)
- K052605EXTERNAL FIXATION2Cleared 510(K)
- K052498FRAGMENT SPECIFIC FIXATOR2Cleared 510(K)
- K052239EBI DYNAFIX VISION FOOTPLATE SYSTEM2Cleared 510(K)
- K051957REPROCESSED EXTERNAL FIXATION DEVICE2Cleared 510(K)
- K052005R&R EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K051616VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES2Cleared 510(K)
- K052062ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES2Cleared 510(K)
- K052064ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES2Cleared 510(K)
- K052065ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES2Cleared 510(K)
- K052037MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K051600SYNTHES (USA) DISTRACTION OSTEOGENESIS SYSTEM2Cleared 510(K)
- K051180VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES2Cleared 510(K)
- K051162GENEROS SB SMALL BONE DISTRACTION IMPLANT2Cleared 510(K)
- K051049SYNTHES (USA) LOW-PROFILE WRIST FIXATOR2Cleared 510(K)
- K051554ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES2Cleared 510(K)
- K051017R-X-FIX EXTERNAL FIXATOR2Cleared 510(K)
- K050849HA COATED LAG SCREW2Cleared 510(K)
- K050457MERETE METAFIX SMALL FRAGMENT BONE PLATE SYSTEM2Cleared 510(K)
- K050048HOFFMAN II MICRO EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K043289E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT2Cleared 510(K)
- K043174STEALTH FUSION SYSTEM, MODEL RR 10002Cleared 510(K)
- K043113TEMPFIX EXTERNAL FIXATION SYSTEM, MR SAFE2Cleared 510(K)
- K043039SYNTHES (USA) EXTERNAL FIXATION COMPONENT LINE EXTENSION - MR SAFE2Cleared 510(K)
- K0338565.0 CANNULATED DRILL PIN, 6.0 CANNULATED DRILL-PIN2Cleared 510(K)
- K042761WRISTORE DISTAL RADIUS FRACTURE FIXATOR, 4600 SERIES2Cleared 510(K)
- K042895SYNTHES LCP DYNAMIC HELICAL HIP SYSTEM, ADDITIONAL HELIX BLADES2Cleared 510(K)
- K042436IIIZAROV PULLEY SYSTEM2Cleared 510(K)
- K042358LOCON VLS DISTAL RADIUS PLATE SYSTEM2Cleared 510(K)
- K042312JET-X BAR CLAMPS AND PIN CLAMPS-NON-MAGNETIC/MR SAFE2Cleared 510(K)
- K042019HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K041911SYNTHES (USA) LCP CURVED PLATES2Cleared 510(K)
- K041706HOFFMANN II FOOT RING2Cleared 510(K)
- K041709NUMELOCK II SYSTEM2Cleared 510(K)
- K040935EBI XFIX DFS SYSTEM2Cleared 510(K)
- K041081FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES2Cleared 510(K)
- K041001OMEGA 2 SYSTEM2Cleared 510(K)
- K031687VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES2Cleared 510(K)
- K040833MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM2Cleared 510(K)
- K040258SYNTHES MEDIUM EXTERNAL FIXATION SYSTEM-MR SAFE2Cleared 510(K)
- K040064NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR2Cleared 510(K)
- K0339953.5 MM LCP DISTAL HUMERUS SYSTEM2Cleared 510(K)
- K033476MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K033556SYNTHES (USA) LCP DYNAMIC HELICAL HIP SYSTEM2Cleared 510(K)
- K033763MODIFICATION TO SLIM GLIDING NAIL SYSTEM2Cleared 510(K)
- K033635MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM2Cleared 510(K)
- K033411SYNTHES (USA) STERILE ADJUSTABLE DISTAL RADIUS FIXATOR (ADRF) WITH 4.0MM/3.0MM SELF-DRILLING SCHANZ SCREWS2Cleared 510(K)
- K033112WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS2Cleared 510(K)
- K033158SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES2Cleared 510(K)
- K031875INTER-OS LIMB LENGTHENER2Cleared 510(K)
- K031919EBI XFIX DFS SYSTEM2Cleared 510(K)
- K031401FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS)2Cleared 510(K)
- K032058MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES2Cleared 510(K)
- K031724SYNTHES SMALL COBINATION CLAMP-MR SAFE2Cleared 510(K)
- K031181EXTERNAL FIXATION SYSTEMS2Cleared 510(K)
- K031093EBI XFIX OPTIROM KNEE FIXATOR2Cleared 510(K)
- K031645EBI XFIX DFS SYSTEM2Cleared 510(K)
- K031725SYNTHES TI-15 MO LOCKING DISTAL RADIUS PLATING SYSTEM2Cleared 510(K)
- K031573SYNTHES 3.5 MM LOW PROFILE PELVIC RECONSTRUCTION PLATE2Cleared 510(K)
- K030372MODIFICATION TO EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM2Cleared 510(K)
- K023714REPROCESSED EXTERNAL FIXATION DEVICE2Cleared 510(K)
- K023851PRECIMED HIP SCREW SYSTEM2Cleared 510(K)
- K023941SYNTHES TOMOFIX OSTEOTOMY SYSTEM2Cleared 510(K)
- K024248MODIFICATION TO EBI XFIX DFS SYSTEM METAPHYSEAL CORRECTION SYSTEM2Cleared 510(K)
- K024129MODIFICATION TO EBI XFIX DFS SYSTEM2Cleared 510(K)
- K023399EBI XFIX DFS SYSTEM2Cleared 510(K)
- K023324MODIFICATION TO EBI XFIX DFS SYSTEM2Cleared 510(K)
- K023314MICROFIX2Cleared 510(K)
- K022771TWIN FIX2Cleared 510(K)
- K022423EXTERNAL FIXATION RING2Cleared 510(K)
- K021933TEMPFIX EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K022319EBI XFIX DFS SYSTEM2Cleared 510(K)
- K012623REPROCESSED EXTERNAL FIXATION DEVICE2Cleared 510(K)
- K012648REPROCESSED HOWMEDICA EXTERNAL FIXATION DEVICES2Cleared 510(K)
- K021695EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM2Cleared 510(K)
- K020772OMEGA II SYSTEM2Cleared 510(K)
- K021312EBI DFS OPTIROM ELBOW FIXATOR2Cleared 510(K)
- K021031EBI XFIX RAIL SYSTEM2Cleared 510(K)
- K021091EBI XFIX DFS SYSTEM2Cleared 510(K)
- K020311CLEARVIEW WRIST FIXATOR2Cleared 510(K)
- K020403MODIFICATION TO EBI XFIX DFS OPTIROM ELBOW FIXATOR2Cleared 510(K)
- K012294WRISTORE FIXATOR2Cleared 510(K)
- K014276MODIFICATION TO EBI XFIX DFS SYSTEM2Cleared 510(K)
- K020240SLIM GLIDING NAIL SYSTEM2Cleared 510(K)
- K020141MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM2Cleared 510(K)
- K014194MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM2Cleared 510(K)
- K013540EBI XFIX ACCESS PELVIC FIXATOR2Cleared 510(K)
- K013503MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR2Cleared 510(K)
- K013378EBI XFIX DFS SYSTEM2Cleared 510(K)
- K012078RADIOFIX2Cleared 510(K)
- K012062PF22Cleared 510(K)
- K011603VHS PEDIATRIC HIP SCREW SYSTEM2Cleared 510(K)
- K012024EBI XFIX DFS SYSTEM2Cleared 510(K)
- K011711MODIFICATION TO EBI EFIX VISION FIXATION SYSTEM2Cleared 510(K)
- K011697EBI XFIX ACCESS PELVIC FIXATOR2Cleared 510(K)
- K011034SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K010766SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATE2Cleared 510(K)
- K010518SYNTHES ANTEROLATERAL CALCANEAL PLATE2Cleared 510(K)
- K010344ADJUSTABLE LARGE FIXATOR SYSTEM2Cleared 510(K)
- K010437MODIFICATION TO EBI XFIX DFS RAIL SYSTEM2Cleared 510(K)
- K003397COLLES C SERIES FRAME STERILE PACK2Cleared 510(K)
- K001358EBI XFIX DFS METAPHYSEAL CORRECTION SYSTEM2Cleared 510(K)
- K000734PIONEER SURGICAL TECHNOLOGY EXTENDED GTR, MODEL 501-6012Cleared 510(K)
- K000682SYNTHES LARGE FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM2Cleared 510(K)
- K000684SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM2Cleared 510(K)
- K000319EBI XFIX DFS SYSTEM2Cleared 510(K)
- K000083EBI XFIX DFS RAIL SYSTEM2Cleared 510(K)
- K993873ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD2Cleared 510(K)
- K993289SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEM2Cleared 510(K)
- K993886EBI XFIX VISION FIXATION SYSTEM2Cleared 510(K)
- K993649EBI XFIX DFS WRISTFIX SYSTEM2Cleared 510(K)
- K991941EBI XFIX DFS RAIL SYSTEM2Cleared 510(K)
- K992515EBI XFIX DFS OPTIROM ELBOW FIXATOR2Cleared 510(K)
- K991806VHS SUPRACONDYLAR PLATE SYSTEM2Cleared 510(K)
- K984364SYNTEC-TAICHUNG NON-STERILE SMALL ORTHOPEDIC FIXATION SYSTEM, MODEL 71100, 294-300,400 & 292-730/8202Cleared 510(K)
- K984498SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM2Cleared 510(K)
- K983873SYNTEC-TAICHUNG NON-STERILE DHS/DCS PLATE SYSTEM2Cleared 510(K)
- K981483EBI DFS JOINT FIXATOR, MODEL 028002Cleared 510(K)
- K980370BIOSYMMETRIC PROXIMAL INTERPHALANGEAL JOINT FIXATOR2Cleared 510(K)
- K974409FRIEDL GLIDING NAIL SYSTEM2Cleared 510(K)
- K974537SYNTHES CANNULATED ANGLE BLADE PLATE (CABP) SYSTEM2Cleared 510(K)
- K973321HOFFMANN II COMPACT PERIARTICULAR CLAMP2Cleared 510(K)
- K973231THE CORIFIX DYNAMIC HIP SCREW SYSTEM2Cleared 510(K)
- K971993ODI COMPRESSION HIP SCREW SYSTEM2Cleared 510(K)
- K973017SYNTHES COMBINATION CLAMP AND DYNAMIZATION CLIP2Cleared 510(K)
- K964880VARI-ANGLE HIP SCREW (VHS) SYSTEM2Cleared 510(K)
- K972629DEPUY AE TK2 HIP SCREW SYSTEM2Cleared 510(K)
- K970748TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K964400ALPHATEC EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K970290EBI X FIX DYNAFIX MINI EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K962251MEDOFF SLIDING PLATE (PROPOSED NAME)2Cleared 510(K)
- K964458ELLIS EXTERNAL MINI-FIXATOR SYSTEM2Cleared 510(K)
- K964094MINIFIX2Cleared 510(K)
- K962484SYNTHES TITANIUM EXTERNAL FIXATOR CLAMPS (TI EFC)2Cleared 510(K)
- K962808ILIZAROV EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K961433EBI X FIX DYNAFIX SYSTEM/EBI DFS DISTAL RADIUS FIXATOR SC BONE SCREWS2Cleared 510(K)
- K961350SYNTHES MINI EXTERNAL FIXATOR2Cleared 510(K)
- K961213ALTA DOME AND PLUNGER (MEC HIP BOLT)2Cleared 510(K)
- K955306OMEGA+ COMPRESSION SCREW SYSTEM2Cleared 510(K)
- K960014PRACTIFIX EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K954555VERSA-FX FEMORAL FIXATION SYSTEM2Cleared 510(K)
- K954712INTRAMEDULLARY HIP SCREW (MODIFICATION)2Cleared 510(K)
- K953406EBI X FIX DYNAFIX SYSTEM (DFS)2Cleared 510(K)
- K951809GLIDING NAIL2Cleared 510(K)
- K951357EBI SMALL EXTERNAL FIXATOR (S/E/F/)2Cleared 510(K)
- K946156DEPUY COMPRESSION HIP SCREW SYSTEM2Cleared 510(K)
- K945233PEDIATRIC OSTEOTOMY SYSTEM2Cleared 510(K)
- K930836HOWMEDICA(R) MONO-TUBE(TM) EXTERNAL FIXATOR SYSTEM2Cleared 510(K)
- K944883GAMMA LOCKING NAIL - LONG LENGTH2Cleared 510(K)
- K926417ALPHATEC 130-150 SLOTTED COMPRESSION HIP SCREW2Cleared 510(K)
- K940286GAMMA LOCKING NAIL MODIFICATION2Cleared 510(K)
- K925460SYNTHES STERILE PINLESS EXTERNAL FIXATOR2Cleared 510(K)
- K932174GAMMA LOCKING NAIL-CROSS LOCKING SCREWS2Cleared 510(K)
- K930156MEGA PLUS SUPER LAG SCREW2Cleared 510(K)
- K923032FIXEL EXTERNAL FIXATION DEVICE2Cleared 510(K)
- K915599CAP WASHER ASSEMBLY2Cleared 510(K)
- K925127ALTA CANCELLOUS BONE SCREW2Cleared 510(K)
- K910993MORREY ELBOW FIXATOR2Cleared 510(K)
- K922295OMEGA PLUS COMPRESS HIP SCREW SYSTEM, MODIFICATION2Cleared 510(K)
- K921786INTRAMEDULLARY HIP SCREW2Cleared 510(K)
- K910483MONOTUBE EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K920608AMERICA SYSTEM2Cleared 510(K)
- K920024RIHARDS TITANIUM HALF PIN2Cleared 510(K)
- K914558TRAUMAFIX (TM) EXTERNAL FIXATOR2Cleared 510(K)
- K910986HOFFMANN DYNAMIC WRIST FIXATOR2Cleared 510(K)
- K912162INTRAMEDULLARY HIP SCREW, MODIFICATION2Cleared 510(K)
- K911021PLATE BLADE WITH CURSOR OF L'UNION2Cleared 510(K)
- K905514AUTOGENESIS(TM) AUTOMATOR2Cleared 510(K)
- K904973EXTERNAL FIXATION2Cleared 510(K)
- K905342LAG SCREW2Cleared 510(K)
- K905338SIDE PLATE2Cleared 510(K)
- K905346JEWETT HIP NAIL2Cleared 510(K)
- K905352BLADE PLATE2Cleared 510(K)
- K901234KIRSCHNER BLADE PLATE SYSTEM OR R.A.B. BLADE PLATE2Cleared 510(K)
- K903250BLADE PLATE2Cleared 510(K)
- K903246SIDE PLATE2Cleared 510(K)
- K903251JEWETT HIP NAIL2Cleared 510(K)
- K901525K-CAPE ORTHOPEDIC WIRES AND PINS2Cleared 510(K)
- K901272ORION BLADE PLATE FOR TIBIAL OSTEOTOMY2Cleared 510(K)
- K900584ALTA LAG SCREW AND COMPRESSION SCREW2Cleared 510(K)
- K890989DR. HERZBERG DISPOSABLE EXTERNAL FIXATOR2Cleared 510(K)
- K895507LINK GIEBEL BLADE PLATE SYSTEM2Cleared 510(K)
- K895241INTRAMEDULLARY HIP SCREW2Cleared 510(K)
- K891066DANEK WRIST FIXATOR2Cleared 510(K)
- K893639GAMMA LOCKING NAIL2Cleared 510(K)
- K890814DANEK RING FIXATOR (DRF)2Cleared 510(K)
- K883715AXIAL COMPRESSION SCREW2Cleared 510(K)
- K882922TECHMEDICA MP SYSTEM2Cleared 510(K)
- K873459ALTA SYSTEMS TIBIAL/UPPER EXTREMITY DIAPHYSEAL PLT2Cleared 510(K)
- K872224MODIFIED TROCHANTER CABLE GRIP SYSTEM2Cleared 510(K)
- K872223MODIFIED OMEGA COMPRESSION HIP SCREW SYSTEM2Cleared 510(K)
- K871248KRONNER COLLES-FOREARM EXTERNAL FIXATION2Cleared 510(K)
- K870786AXIAL COMPRESSION SCREW2Cleared 510(K)
- K871247KRONNER UNIVERSAL FRAME EXTERNAL FIXATION2Cleared 510(K)
- K871249KRONNER BI-PLANER TIBIA EXTERNAL FIXATION2Cleared 510(K)
- K870961RICHARDS EXTERNAL FIXATION SYSTEM2Cleared 510(K)
- K863343SUPERFIXATION(TM)2Cleared 510(K)
- K862311SCREW DRIVER/BONE SCREW WRENCH/TAP & GUIDE PIN2Cleared 510(K)
- K861178DEPUY COMPRESSION HIP SCREW SYSTEM2Cleared 510(K)
- K854205KIRSCHNER COMPRESSION HIP SCREW SYSTEM2Cleared 510(K)
- K850443MEC ROD CONNECTOR2Cleared 510(K)
- K850413MEC HIP BOLT2Cleared 510(K)
- K850403MEC DISTAL FEMORAL BOLT2Cleared 510(K)
- K851919SUPRACONDYLAR BONE PLATE2Cleared 510(K)
- K844068TROCHANTER CABLE GRIP SYSTEM2Cleared 510(K)
- K843449AUTODYNAMIC COMPRESSION HIP SCREW-PLATE2Cleared 510(K)
- K842695T.O.D. PLATE SYS STERILE2Cleared 510(K)
- K842681T.O.D. PLATE SYSTEM2Cleared 510(K)
- K842768ACE/FISHER EXTERNAL FIXATOR2Cleared 510(K)
- K830196CORSTREN COMPRESSION TUBE & PLATE2Cleared 510(K)
- K823548COMPRESSION HIP SCREW SIDE-PLATE2Cleared 510(K)
- K813554ACE/KYLE CAPTURED HIP SCREW2Cleared 510(K)
- K811017HUCKSTEP INTRAMEDULLARY NAIL2Cleared 510(K)
- K791619DYNAMIC HIP SCREW2Cleared 510(K)
- K790501PEDIATRIC OSTEOTOMY SYSTEM2Cleared 510(K)
- 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
Galaxy UNYCO System
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K170146
- 510(k) Type
- Traditional
- Applicant
- Orthofix Srl
- Country
- Italy
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/12/2017
- Days to Decision
- 268 days
- Submission Type
- Summary