meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
37
Latest Decision
2006-08-03

Clearances · page 101 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K060474 LISFRANC PLATE New Deal, S.A. HRS Class II 2006-08-03
K061836 AVS ASL PEEK SPACER SYSTEM Stryker Spine MQP Class II 2006-08-03
K062037 TRIATHLON LOW PROFILE TIBIAL TRAY Howmedica Osteonics Corp. JWH Class II 2006-08-03
K061226 TRABECULAR METAL ACETABULAR REVISION SYSTEM CAGE Zimmer, Inc. LPH Class II 2006-08-02
K061344 EXCIA TOTAL HIP SYSTEM LATERAL OFFSET Aesculap, Inc. JDI Class II 2006-08-02
K061882 OXYGENLESS PACKAGING CONVERSION OF LEGACY CENTERPULSE STANDARD POLYETHYLENE DEVICES Zimmer, Inc. JWH Class II 2006-08-01
K061423 M2A MAGNUM 12/14 TAPER INSERTS AND ONE-PIECE MODULAR HEADS Biomet Manufacturing Corp KWA Class III 2006-07-27
K061621 SYNTHES (USA) 6.5 MM CANCELLOUS SCREWS Synthes (Usa) HWC Class II 2006-07-27
K061854 XIA TITANIUM SPINAL SYSTEM AND XIA STAINLESS STEEL SPINAL SYSTEM Stryker Spine NKB Class II 2006-07-27
K061599 PIN SCREW Bk Meditech, Co., Ltd. JDW Class II 2006-07-26
K061482 ALTES BUTTRESS PLATING SYSTEM Altiva Corp. KWQ Class II 2006-07-26
K061620 IFS CANNULATED BONE SCREW Internal Fixation Systems, Inc. HWC Class II 2006-07-26
K061162 BAR PEDICLE SCREW SPINAL FIXATION SYSTEM, MODEL 2020 Applied Spine Technologies, Inc. MNH Class II 2006-07-26
K061665 ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FT Arthrex, Inc. HWC Class II 2006-07-25
K061441 EBI 5.5 HELICAL FLANGE SPINAL SYSTEM Ebi, L.P. MNH Class II 2006-07-25
K061657 HITCH LACTOSORB SUTURE ANCHOR Arthrotek, Inc. JDR Class II 2006-07-25
K061915 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek MNH Class II 2006-07-25
K061786 VERSYS FIBER METAL MIDCOAT LOW HEAD CENTER HIP PROSTHESIS Zimmer, Inc. LPH Class II 2006-07-24
K061229 UNITY LX ANTEROLATERAL LUMBAR PLATE FIXATION SYSTEM Blackstone Medical, Inc. KWQ Class II 2006-07-24
K061151 PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER) Pioneer Surgical Technology MQP Class II 2006-07-24
K061202 REVERE STABILIZATION SYSTEM Globus Medical, Inc. NKB Class II 2006-07-20
K061439 AEQUALIS REVERSED PROSTHESIS Tornier PHX Class II 2006-07-20
K053417 M-COR HIP REPLACEMENT SYSTEM Portland Orthopaedics Pty. , Ltd. LPH Class II 2006-07-20
K061146 SBI ULNAR HEAD IMPLANT Small Bone Innovations, Inc. KXE Class II 2006-07-19
K061389 ALLTHREAD LACTOSORB SUTURE ANCHOR Arthrotek, Inc. JDR Class II 2006-07-19
K061294 KFX KNOTLESS FIXATION SYSTEM Kfx Medical MBI Class II 2006-07-19
K061939 MODIFICATION TO ALLOMATRIX CUSTOM Wrightmedicaltechnologyinc MQV Class II 2006-07-18
K061124 ORTHOPEDIC SOURCE PRESS-FIT HIP Orthopedic Source, Inc. LPH Class II 2006-07-18
K061765 KALIX II IMPLANT New Deal, S.A. HWC Class II 2006-07-18
K061304 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek NQP Class II 2006-07-18
K061607 STORM OPERATING KIT, MODEL 1-10-0 Intelligent Orthopaedics, Ltd. HTY Class II 2006-07-18
K061778 NUVASIVE SPHERX II SYSTEM Nuvasive, Inc. MNH Class II 2006-07-18
K061168 PCA 36MM FEMORAL HEADS Howmedica Osteonics Corp. LPH Class II 2006-07-18
K061833 DEPUY AML HIP PROSTHESIS DePuy Orthopaedics, Inc. LPH Class II 2006-07-17
K053624 MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEM Medicon EG HRS Class II 2006-07-17
K061243 SMITH & NEPHEW MODULAR FEMORAL HEAD Smith & Nephew, Inc. KWL Class II 2006-07-17
K061748 FRAGMENT PLATE SYSTEM Hand Innovations, LLC KTT Class II 2006-07-17
K061066 SYNERGY HIP SYSTEM Smith & Nephew, Inc. LZO Class II 2006-07-14
K061349 OPUS LABRALOCK P KNOTLESS FIXATION DEVICE Arthrocare Corp. MBI Class II 2006-07-14
K053246 PATIENT MATCHED HIP STEM Smith & Nephew, Inc. LZO Class II 2006-07-12
K060425 PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS-TA Arthrocare Corp. NDN Class II 2006-07-12
K053623 NFIX FUSION SYSTEM N-Spine, Inc. MNH Class II 2006-07-12
K061011 COMPETITOR UNICONDYLAR KNEE TIBIAL BASEPLATE Smith & Nephew, Inc. HSX Class II 2006-07-11
K061677 SOLAR PUREFIX HA SHOULDER Howmedica Osteonics Corp. HSD Class II 2006-07-10
K061654 TRIDENT CONSTRAINED ACETABULAR INSERT Howmedica Osteonics Corp. KWZ Class II 2006-07-07
K061321 ZODIAC ADJUSTABLE BRIDGES, MODELS 11-20XX,11-25XX,11-30XX,11-35XX Alphatec Spine, Inc. MNH Class II 2006-07-07
K061493 APEX PINS Stryker Howmedica Osteonics JDW Class II 2006-07-07
K053213 BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM Berkeley Advanced Biomaterials, Inc. MQV Class II 2006-07-06
K061498 ALLOFIX ANCHOR, 5.0 MM ANCHOR Musculoskeletal Transplant Foundation JDW Class II 2006-07-06
K060569 BALANCED KNEE SYSTEM MODULAR REVISION KNEE SYSTEM Ortho Development Corp. JWH Class II 2006-07-06
K061164 ACTIVAPIN Bioretec, Ltd. HTY Class II 2006-07-06
K061569 SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTS Smith & Nephew, Inc. NPJ Class II 2006-07-06
K060970 AXYALOOP NONABSORBABLE BONE ANCHOR Axya Medical, Inc. JDR Class II 2006-07-05
K061262 LIGAFIX INTERFERENCE SCREW Sciences For Bio Materials HWC Class II 2006-07-05
K060809 OSTEO-LINK BONE VOID FILLER PELLETS Promed Advance Technology Co., Ltd. MQV Class II 2006-07-03
K061576 MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM Quantum Orthopedics, Inc. MQP Class II 2006-07-03
K061592 MODIFICATION TO CD HORIZON SYSTEM Medtronic Sofamor Danek, Inc. NKB Class II 2006-07-03
K061594 LARGE UNI-CLIP STAPLE New Deal, S.A. JDR Class II 2006-07-03
K061547 DYNASTY ACETABULAR SHELL; DYNASTY A-CLASS POLY ACETABULAR LINER Wrightmedicaltechnologyinc LPH Class II 2006-07-03
K053336 STAXX FX SYSTEM Spine Wave, Inc. NDN Class II 2006-07-03
K051704 MYKRES SPINAL SYSTEM Showa Ika Kohgyo Co., Ltd. MNI Class II 2006-07-03
K061147 OPTERYX ANTERIOR CERVICAL PLATE SYSTEM Innovasis, Inc. KWQ Class II 2006-06-30
K061400 CALCANEAL TRAUMA SYSTEM Orthohelix Surgical Designs, Inc. HRS Class II 2006-06-29
K060874 DEPUY GLOBAL AP SHOULDER SYSTEM DePuy Orthopaedics, Inc. KWS Class II 2006-06-28
K061520 VIPER SPINE SYSTEM Depuy Spine, Inc. NKB Class II 2006-06-23
K061563 EBI ARRAY SPINAL SYSTEM Ebi, L.P. NKB Class II 2006-06-23
K060702 4CIS VANE SPINE SYSTEM Solco Biomedical Co., Ltd. MNH Class II 2006-06-22
K060300 CONFIDENCE HIGH VISCOSITY BONE CEMENT Disc-O-Tech Medical Technologies, Ltd. NDN Class II 2006-06-21
K061089 MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599 Biopro, Inc. KYI Class II 2006-06-20
K061206 ACUTE BONE SCREW Acute Innovations, LLC HWC Class II 2006-06-19
K051965 OSTEOBRIDGE IDSF INTRAMEDULLARY DIAPHYSEAL SEGMENTAL DEFECT FIXATION ROD SYSTEM Merete Medical GmbH HSB Class II 2006-06-16
K060192 APEX KNEE SYSTEM Omni Life Science, Inc. JWH Class II 2006-06-15
K060830 MILAGRO INTERFERENCE SCREW Depuy Mitek, A Johnson & Johnson Company HWC Class II 2006-06-15
K061211 NCB PLATING SYSTEM, PROXIMAL TIBIA PLATES Zimmer GmbH HRS Class II 2006-06-14
K060630 REFLECTION 3-HOLE SHELL WITH ASYMMETRIC POROUS COATING Smith & Nephew, Inc. LPH Class II 2006-06-14
K061454 EXACTECH EQUINOXE SHOULDER STEMS Exactech, Inc. HSD Class II 2006-06-12
K060248 ULTRATINE TRANSBLEPH Coapt Systems, Inc. HWC Class II 2006-06-12
K060249 ULTRATINE FOREHEAD Coapt Systems, Inc. HWC Class II 2006-06-12
K060716 VERSA-DIAL HUMERAL HEAD PROSTHESIS Biomet Manufacturing Corp MBF Class II 2006-06-12
K060914 TRIDENT ANCHOR Johnson & Johnson Company HWC Class II 2006-06-09
K061380 RETAIN RADIOLUCENT SPACER Globus Medical, Inc. MQP Class II 2006-06-08
K061154 KINSA SUTURE ANCHOR Smith & Nephew, Inc. MBI Class II 2006-06-08
K061144 DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT DePuy Orthopaedics, Inc. MBB Class II 2006-06-08
K061016 EBI ESL PEEK-OPTIMA SPINE SYSTEM Ebi, L.P. MQP Class II 2006-06-08
K060916 ATLAS SPINAL CAGE, MODELS SC-150-007, 009, 011, 013, 015, 017. Spinal Edge, LLC MQP Class II 2006-06-08
K060118 SSP PEDICLE SCREW SYSTEM Specialty Spine Products, LLC MNH Class II 2006-06-08
K061352 PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM FOR THE UPPER EXTREMITY Smith & Nephew, Inc. HRS Class II 2006-06-08
K061019 TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS Smith & Nephew, Inc. JDS Class II 2006-06-06
K061384 LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUM Walter Lorenz Surgical, Inc. HRS Class II 2006-06-06
K060693 MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHOR Arthrotek, Inc. HWC Class II 2006-06-06
K060664 FASTIN RC ANCHOR Depuy Mitek HWC Class II 2006-06-06
K061345 MODIFICATION TO ENDIUS ATAVI SYSTEM Endius, Inc. HRX Class II 2006-06-06
K061312 36MM BIOLOX DELTA CERAMIC HEADS Biomet, Inc. LZO Class II 2006-06-06
K060536 OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM Osteomed LP KWD Class II 2006-06-02
K060670 ACCIN UNI-KNEE SYSTEM Accin Corporation HSX Class II 2006-06-02
K060707 AESCULAP BIPOLAR ACETABULAR CUP Aesculap, Inc. KWY Class II 2006-05-31
K061253 REFLECTION 3 ACETABULAR SYSTEM Smith & Nephew, Inc. MBL Class II 2006-05-31
K060172 REMA SHAVER BLADES Rema Medizintechnik GmbH. HRX Class II 2006-05-31
K060692 COMPREHENSIVE PRIMARY SHOULDER STEMS Biomet Manufacturing Corp MBF Class II 2006-05-30
K060722 NEXGEN COMPLETE KNEE SOLUTION ULTRACONGRUENT (UC-FLEX) FIXED BEARING ARTICULAR SURFACE COMPONENT Zimmer, Inc. JWH Class II 2006-05-26

17,115 clearances in the Orthopedic panel. Data: openFDA.