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Orthopedic

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

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RecordFirmDate
REPROCESSED STRYKER ARTHROSCOPIC SHAVERS (K012635)Alliance Medical Corp.2001-11-07
MODIFICATION TO: STACKABLE CAGE SYSTEM (K013382)Depuyacromed2001-11-07
TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL, MODEL 8119, 8120, 8130, 8131 (K010989)Interpore Cross Intl.2001-11-07
SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT (K011985)Smith & Nephew, Inc.2001-11-02
ADVANCE UNICONDYLAR KNEE SYSTEM (K012591)Wrightmedicaltechnologyinc2001-11-02
REPROCESSED POWERED ARTHROSCOPIC ACCESSORIES (K012536)Sterilmed, Inc.2001-11-02
KADANCE 2000 (K012492)Kada Research, Inc.2001-11-02
PALAMED BONE CEMENT (K010586)Merck Biomaterial GmbH2001-10-30
MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR (K012465)Bonutti Research, Inc.2001-10-29
OSTEOSET BVF KIT (K010532)Wrightmedicaltechnologyinc2001-10-26
LIFT VB SPINAL SYSTEM (K010930)Medtronic Sofamor Danek, Inc.2001-10-24
PASS SPINAL SYSTEM (K013191)Encore Orthopedics, Inc.2001-10-24
METAL SCREW ANCHOR (K012503)Biomet Manufacturing, Inc.2001-10-22
AML HIP PROSTHESIS (K012364)DePuy Orthopaedics, Inc.2001-10-19
SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM (K012961)Sulzer Orthopedics, Inc.2001-10-18
VANGUARD REPROCESSED ARTHROSCOPIC BLADES (K012346)Vanguard Medical Concepts, Inc.2001-10-16
VBR (K012254)Osteotech, Inc.2001-10-16
BIOCUFF,C, MODELS 236018, 236028, 236036 (K013057)Bionx Implants, Inc.2001-10-12
EPOCA CUSTOM OFFSET SHOULDER SYSTEM (K010869)Argomedical AG2001-10-11
DURACON PS LIPPED TIBIAL INSERT (K012172)Howmedica Osteonics2001-10-10
DISCOVERY ELBOW (K013042)Biomet Orthopedics, Inc.2001-10-10
MONARCH SPINAL SYSTEMS (K013294)Depuyacromed2001-10-09
MOSS MIAMI SPINAL SYSTEMS (K013296)Depuyacromed2001-10-09
TIMX SPINAL SYSTEMS (K013295)Depuyacromed2001-10-09
ISOLA SPINAL SYSTEMS (K012971)Depuyacromed2001-10-05
MODIFICATION TO FIXION INTERLOCKING PROXIMAL FEMORAL INTRAMEDULLARY NAILING SYSTEM (K012967)Disco-O-Tech Medical Technologies, Ltd.2001-10-04
PRO-FEMUR (K012091)Wrightmedicaltechnologyinc2001-10-03
DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM (K012081)Medtronic Sofamor Danek, Inc.2001-10-01
SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM (K012114)Synthes (Usa)2001-09-28
VERTEX RECONSTRUCTION SYSTEM (K003780)Medtronic Sofamor Danek, Inc.2001-09-28
DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM (K012173)Sulzer Spine-Tech2001-09-28
STRYKER CROSS-PINNED INTERFERENCE SCREW SYSTEM (K012270)Stryker Endoscopy2001-09-28
PF2 (K012062)Fixano SA2001-09-27
RADIOFIX (K012078)Fixano SA2001-09-27
THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0 (K012866)Implex Corp.2001-09-26
XIA STAINLESS STEEL SYSTEM (K012870)Howmedica Osteonics Corp.2001-09-24
AOS MODULAR FEMORAL NAIL (K012190)Advanced Orthopaedic Solutions, Inc.2001-09-24
COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), MODEL 1X,3X,6X (1,3 OR 6 STRIPS PER BOX) (K000122)Neucoll, Inc.2001-09-20
SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE (K011954)Sulzer Orthopedics, Inc.2001-09-19
CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116 (K012334)Bionx Implants, Inc.2001-09-19
OPUS MAGNUM ANCHOR & INSERTER (K012125)Opus Medical, Inc.2001-09-17
COPELAND MB/HA RESURFACING HUMERAL HEADS (K010827)Biomet Orthopedics, Inc.2001-09-14
COPELAND MB RESURFACING HUMERAL HEADS (K010657)Biomet Manufacturing, Inc.2001-09-14
SYNERGY TI INTEGRAL OPEN SCREWS MODELS # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176, 6177 (K012871)Interpore Cross Intl.2001-09-13
SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM (K011857)Synthes (Usa)2001-09-12
ARTSCAN CARTILAGE STIFFNESS TESTING DEVICE (K010303)Artscan Medical Innovations2001-09-11
MPF ACETABULAR CUP (K011836)Plus Orthopedics2001-09-07
ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING (K011810)Depuy, Inc.2001-09-07
MODIFICATION TO THE I.C.O.S SCREW (K011821)New Deal, S.A.2001-09-06
SYNTHES LCP PROXIMAL HUMERUS PLATES (K011815)Synthes (Usa)2001-09-06
MODIFICATION TO THE TAC' PIN (K011875)New Deal, S.A.2001-09-06
R120 MODULAR TOTAL HIP SYSTEM (K011774)Osteoimplant Technology, Inc.2001-09-05
STRYKER PLATING SYSTEM BASIC FRAGMENT SET (K012162)Howmedica Osteonics Corp.2001-08-31
MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000 (K011912)Axya Medical, Inc.2001-08-31
THE TRABECULAR METAL TECHNOLOGY ACETABULAR AUGMENT SYSTEM, MODELS 4893-XX-YY (ZIMMER), 02-212-05XX1 ( IMPLEX) (K012507)Implex Corp.2001-08-30
THE UNI-CLIP STAPLE (K011716)New Deal, S.A.2001-08-30
VULCAN TAC PROBES, MODEL 911XXX (K003198)Oratec Interventions, Inc.2001-08-29
ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0 (K012493)Exactech, Inc.2001-08-29
ORTELIUS 800 (K011827)Orthoscan , Ltd.2001-08-28
MACROPORE IB RESORBABLE PLUG (K011715)Macropore Biosurgery, Inc.2001-08-27
FLEX-NAILS (K012161)Fixano SA2001-08-24
THE SPIN SNAP-OFF SCREW (K011946)New Deal, S.A.2001-08-24
MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM (K012305)Sulzer Spine-Tech2001-08-22
INTERLOK / HA COPELAND RESURFACING HEADS (K010635)Biomet, Inc.2001-08-20
TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2 (K012280)Triage Medical, Inc.2001-08-17
SPIRAL RADIUS 90-D SST SYSTEM (K012273)United States Surgical, A Division of Tyco Healthc2001-08-15
VHS PEDIATRIC HIP SCREW SYSTEM (K011603)Walter Abendschein, M.D.2001-08-15
MAXIM RPG PS FEMORAL COMPONENT (K012348)Biomet, Inc.2001-08-15
MODIFICATION TO AEQUALIS SHOULDER SYSTEM (K012212)Tornier2001-08-15
BAUMER LOCKING NAIL (K011504)Baumer, S.A2001-08-14
SYNTHES LCP PROXIMAL TIBIA PLATE (K011978)Synthes (Usa)2001-08-09
SCS CLARIS SPINAL SCREWS, TYPES V,G,E (K011807)Ortho Tec, LLC2001-08-07
WUJIN #3 FEMORAL BONE PLATE (K011459)Biopro, Inc.2001-08-07
WUJIN #3 TIBIAL BONE PLATE (K011460)Biopro, Inc.2001-08-07
EBI OSTEOSTIM GRANULES-RESORBABLE BONE GRAFT SUBSTITUTE (K011386)Ebi, L.P.2001-08-03
GEO STRUCTURE (K010530)Interpore Cross Intl.2001-08-03
KSEA MANHES TAKE-APART BIPOLAR COAGULATING FORCEPS (K010345)KARL STORZ Endoscopy-America, Inc.2001-08-03
ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM (K011102)Aesculap, Inc.2001-08-03
SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM (K011458)Synthes (Usa)2001-08-02
CANNULATED PLUS SCREW SYSTEM (K010738)Orthomatrix, Inc.2001-08-01
MODIFICATION TO: LONG LENGTH GAMMA NAIL (K012158)Howmedica Osteonics Corp.2001-08-01
ARTHREX BIO-POST AND WASHER (K011495)Arthrex, Inc.2001-08-01
OPTETRAK TOTAL KNEE SYSTEM, STRAIGHT STEM EXTENSIONS - ADDITIONAL SIZES (K012251)Exactech, Inc.2001-07-31
PASS SPINAL SYSTEM (K012175)Encore Orthopedics, Inc.2001-07-31
HIGH TIBIAL OSTEOTOMY PLATING SYSTEM (K011354)Dj Orthopedics, LLC2001-07-31
RESORBABLE BONE PINS (K011522)Biomet, Inc.2001-07-31
SUMMIT DUOFIX HIP PROSTHESIS (K011489)DePuy Orthopaedics, Inc.2001-07-31
SYNTHS ONE-THIRD TUBULAR DCL PLATE (K011335)Synthes (Usa)2001-07-27
SYNTHES CURVED RECONSTRUCTION PLATE (K011334)Synthes (Usa)2001-07-27
THE LPS - CONTINUUM TM HYBRID TIBIA, MODELS 32-5886-2Y-XX (ZIMMER) AND 05-119-XXYY1-0 (IMPLEX) (K012095)Implex Corp.2001-07-26
EBI XFIX DFS SYSTEM (K012024)Ebi, L.P.2001-07-25
TRI-FIX SPINAL FIXATION SYSTEM (K011830)Endius, Inc.2001-07-23
MACROPORE OS SPINAL SYSTEM (K010911)Macropore Biosurgery, Inc.2001-07-20
NORMED EXTREMITY TITANIUM HAND AND SMALL FRAGMENT SYSTEM (K011118)Osteomedics2001-07-20
STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX (K011319)Stryker Endoscopy2001-07-20
ARTHROSCOPES (K003831)Global Endoscopy, Inc.2001-07-20
MODIFICATION TO XIA SPINE SYSTEM (K012027)Howmedica Osteonics2001-07-20
COLOR BUFFED (CB) DDH FEMORAL STEM (K012019)Biomet, Inc.2001-07-20
PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS050, 2RCS075, 2RCS10, 2RCS15, 2RCS20, 2RCS225, 2RCS30 (K004003)Interpore Cross Intl.2001-07-19
NEXGEN PRIMARY POROUS PATELLA, MODEL 04-211-IIII-5878-65-ZZ-(STANDARD),04-212-IIII-5878-61-ZZ-(MICRO) (K011904)Implex Corp.2001-07-19
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