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Orthopedic

17,044 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
BIOKNOTLESS AND LUPINE PLUS ANCHORS (K062170)Depuy Mitek, A Johnson & Johnson Company2006-08-22
BIOPRO MEMORY STAPLE (K061798)Biopro, Inc.2006-08-21
VANGUARD ANATOMIC PATELLA GROOVE (APG) / VANGUARD V GROOVE (K061433)Biomet Manufacturing, Inc.2006-08-21
EXCIA (K061699)Aesculap, Inc.2006-08-18
DELTA CTA REVERSE SHOULDER SYSTEM HUMERAL HEADS (K062116)DePuy Orthopaedics, Inc.2006-08-18
SYNEX II (K061891)Synthes Spine Co.Lp2006-08-18
ADVANCE TOTAL KNEE SYSTEM (K061223)Wrightmedicaltechnologyinc2006-08-18
INTERPLATE VBR SYSTEM (K061401)Rsb Spine, LLC2006-08-18
REFLEX HYBRID ACP SYSTEM (K062310)Stryker Spine2006-08-18
DARCO LOCKING BONE PLATE SYSTEM (K061808)Darco International, Inc.2006-08-17
VERTEBRON SCP CERVICAL PLATE SYSTEM (K062110)Vertebron, Inc.2006-08-16
AVS PL PEEK SPACER SYSTEM (K062132)Stryker Spine2006-08-16
SPINAL USA VBR SYSTEM (K061752)Spinal USA2006-08-15
MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT (K062004)Quantum Orthopedics, Inc.2006-08-15
OMEGA 3 SYSTEM (K062066)Howmedica Osteonics Corp.2006-08-15
REGENEREX ULTRA POROUS CONSTRUCT-FEMORAL AND TIBIAL KNEE AUGMENTS (K053505)Biomet Manufacturing, Inc.2006-08-14
VERTE-STACK SPINAL SYSTEM (K062073)Medtronic Sofamor Danek2006-08-14
TRIATHLON METAL BACKED PATELLA (K061521)Howmedica Osteonics Corp.2006-08-11
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K061579)Medtronic Sofamor Danek2006-08-11
EBI, L.P.'S LINE EXTENSION TO THE ARRAY SPINAL SYSTEM (K061978)Ebi, L.P.2006-08-11
ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 (K061451)Ascension Orthopedics, Inc.2006-08-11
LATERAL PLATE SYSTEM (K061789)Nuvasive, Inc.2006-08-10
EASYSPINE SYSTEM (K061017)Ldr Spine USA2006-08-10
KNEE FUSION NAIL (K061783)Smith & Nephew, Inc.2006-08-10
VERTE-STACK SPINAL SYSTEM (K061938)Medtronic Sofamor Danek, Inc.2006-08-09
2.8 & 3.5MM LACTOSCREW SUTURE ANCHORS (K061801)Arthrotek, Inc.2006-08-07
SYNTHES (USA) CLAVICLE HOOK PLATES (K061753)Synthes (Usa)2006-08-04
RAYHACK LOW PROFILE LOCKING PLATE AND INSTRUMENTS (K061955)Creative Medical Designs, Inc.2006-08-04
COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE (K061779)Smith & Nephew, Inc.2006-08-04
LISFRANC PLATE (K060474)New Deal, S.A.2006-08-03
TRIATHLON LOW PROFILE TIBIAL TRAY (K062037)Howmedica Osteonics Corp.2006-08-03
AVS ASL PEEK SPACER SYSTEM (K061836)Stryker Spine2006-08-03
EXCIA TOTAL HIP SYSTEM LATERAL OFFSET (K061344)Aesculap, Inc.2006-08-02
TRABECULAR METAL ACETABULAR REVISION SYSTEM CAGE (K061226)Zimmer, Inc.2006-08-02
OXYGENLESS PACKAGING CONVERSION OF LEGACY CENTERPULSE STANDARD POLYETHYLENE DEVICES (K061882)Zimmer, Inc.2006-08-01
SYNTHES (USA) 6.5 MM CANCELLOUS SCREWS (K061621)Synthes (Usa)2006-07-27
XIA TITANIUM SPINAL SYSTEM AND XIA STAINLESS STEEL SPINAL SYSTEM (K061854)Stryker Spine2006-07-27
M2A MAGNUM 12/14 TAPER INSERTS AND ONE-PIECE MODULAR HEADS (K061423)Biomet Manufacturing Corp2006-07-27
ALTES BUTTRESS PLATING SYSTEM (K061482)Altiva Corp.2006-07-26
IFS CANNULATED BONE SCREW (K061620)Internal Fixation Systems, Inc.2006-07-26
PIN SCREW (K061599)Bk Meditech, Co., Ltd.2006-07-26
BAR PEDICLE SCREW SPINAL FIXATION SYSTEM, MODEL 2020 (K061162)Applied Spine Technologies, Inc.2006-07-26
HITCH LACTOSORB SUTURE ANCHOR (K061657)Arthrotek, Inc.2006-07-25
ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FT (K061665)Arthrex, Inc.2006-07-25
EBI 5.5 HELICAL FLANGE SPINAL SYSTEM (K061441)Ebi, L.P.2006-07-25
CD HORIZON SPINAL SYSTEM (K061915)Medtronic Sofamor Danek2006-07-25
PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER) (K061151)Pioneer Surgical Technology2006-07-24
VERSYS FIBER METAL MIDCOAT LOW HEAD CENTER HIP PROSTHESIS (K061786)Zimmer, Inc.2006-07-24
UNITY LX ANTEROLATERAL LUMBAR PLATE FIXATION SYSTEM (K061229)Blackstone Medical, Inc.2006-07-24
AEQUALIS REVERSED PROSTHESIS (K061439)Tornier2006-07-20
REVERE STABILIZATION SYSTEM (K061202)Globus Medical, Inc.2006-07-20
M-COR HIP REPLACEMENT SYSTEM (K053417)Portland Orthopaedics Pty. , Ltd.2006-07-20
ALLTHREAD LACTOSORB SUTURE ANCHOR (K061389)Arthrotek, Inc.2006-07-19
KFX KNOTLESS FIXATION SYSTEM (K061294)Kfx Medical2006-07-19
SBI ULNAR HEAD IMPLANT (K061146)Small Bone Innovations, Inc.2006-07-19
MODIFICATION TO ALLOMATRIX CUSTOM (K061939)Wrightmedicaltechnologyinc2006-07-18
STORM OPERATING KIT, MODEL 1-10-0 (K061607)Intelligent Orthopaedics, Ltd.2006-07-18
PCA 36MM FEMORAL HEADS (K061168)Howmedica Osteonics Corp.2006-07-18
NUVASIVE SPHERX II SYSTEM (K061778)Nuvasive, Inc.2006-07-18
CD HORIZON SPINAL SYSTEM (K061304)Medtronic Sofamor Danek2006-07-18
KALIX II IMPLANT (K061765)New Deal, S.A.2006-07-18
ORTHOPEDIC SOURCE PRESS-FIT HIP (K061124)Orthopedic Source, Inc.2006-07-18
SMITH & NEPHEW MODULAR FEMORAL HEAD (K061243)Smith & Nephew, Inc.2006-07-17
FRAGMENT PLATE SYSTEM (K061748)Hand Innovations, LLC2006-07-17
DEPUY AML HIP PROSTHESIS (K061833)DePuy Orthopaedics, Inc.2006-07-17
MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEM (K053624)Medicon EG2006-07-17
SYNERGY HIP SYSTEM (K061066)Smith & Nephew, Inc.2006-07-14
OPUS LABRALOCK P KNOTLESS FIXATION DEVICE (K061349)Arthrocare Corp.2006-07-14
PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS-TA (K060425)Arthrocare Corp.2006-07-12
NFIX FUSION SYSTEM (K053623)N-Spine, Inc.2006-07-12
PATIENT MATCHED HIP STEM (K053246)Smith & Nephew, Inc.2006-07-12
COMPETITOR UNICONDYLAR KNEE TIBIAL BASEPLATE (K061011)Smith & Nephew, Inc.2006-07-11
SOLAR PUREFIX HA SHOULDER (K061677)Howmedica Osteonics Corp.2006-07-10
ZODIAC ADJUSTABLE BRIDGES, MODELS 11-20XX,11-25XX,11-30XX,11-35XX (K061321)Alphatec Spine, Inc.2006-07-07
APEX PINS (K061493)Stryker Howmedica Osteonics2006-07-07
TRIDENT CONSTRAINED ACETABULAR INSERT (K061654)Howmedica Osteonics Corp.2006-07-07
BALANCED KNEE SYSTEM MODULAR REVISION KNEE SYSTEM (K060569)Ortho Development Corp.2006-07-06
ACTIVAPIN (K061164)Bioretec, Ltd.2006-07-06
SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTS (K061569)Smith & Nephew, Inc.2006-07-06
BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM (K053213)Berkeley Advanced Biomaterials, Inc.2006-07-06
ALLOFIX ANCHOR, 5.0 MM ANCHOR (K061498)Musculoskeletal Transplant Foundation2006-07-06
LIGAFIX INTERFERENCE SCREW (K061262)Sciences For Bio Materials2006-07-05
AXYALOOP NONABSORBABLE BONE ANCHOR (K060970)Axya Medical, Inc.2006-07-05
OSTEO-LINK BONE VOID FILLER PELLETS (K060809)Promed Advance Technology Co., Ltd.2006-07-03
MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM (K061576)Quantum Orthopedics, Inc.2006-07-03
MYKRES SPINAL SYSTEM (K051704)Showa Ika Kohgyo Co., Ltd.2006-07-03
STAXX FX SYSTEM (K053336)Spine Wave, Inc.2006-07-03
DYNASTY ACETABULAR SHELL; DYNASTY A-CLASS POLY ACETABULAR LINER (K061547)Wrightmedicaltechnologyinc2006-07-03
MODIFICATION TO CD HORIZON SYSTEM (K061592)Medtronic Sofamor Danek, Inc.2006-07-03
LARGE UNI-CLIP STAPLE (K061594)New Deal, S.A.2006-07-03
OPTERYX ANTERIOR CERVICAL PLATE SYSTEM (K061147)Innovasis, Inc.2006-06-30
CALCANEAL TRAUMA SYSTEM (K061400)Orthohelix Surgical Designs, Inc.2006-06-29
DEPUY GLOBAL AP SHOULDER SYSTEM (K060874)DePuy Orthopaedics, Inc.2006-06-28
EBI ARRAY SPINAL SYSTEM (K061563)Ebi, L.P.2006-06-23
VIPER SPINE SYSTEM (K061520)Depuy Spine, Inc.2006-06-23
4CIS VANE SPINE SYSTEM (K060702)Solco Biomedical Co., Ltd.2006-06-22
CONFIDENCE HIGH VISCOSITY BONE CEMENT (K060300)Disc-O-Tech Medical Technologies, Ltd.2006-06-21
MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599 (K061089)Biopro, Inc.2006-06-20
ACUTE BONE SCREW (K061206)Acute Innovations, LLC2006-06-19
OSTEOBRIDGE IDSF INTRAMEDULLARY DIAPHYSEAL SEGMENTAL DEFECT FIXATION ROD SYSTEM (K051965)Merete Medical GmbH2006-06-16
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