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Orthopedic

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

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RecordFirmDate
ADI 9000/9001 ARTHROSCOPE AND ACCESSORIES (K992621)Advanced Diagnostics & Interventions1999-11-08
ISOBAR SPINAL SYSTEM (K992738)Encore Orthopedics, Inc.1999-11-08
ISOBAR SEMI-RIGID SPINAL SYSTEM (K991326)Scien'Tx USA, Inc.1999-11-08
TITANIUM HARTSHILL SYSTEM (K991662)Surgicraft , Ltd.1999-11-08
DEPUY TOTAL ELBOW SYSTEM (K992656)DePuy Orthopaedics, Inc.1999-11-05
SYNTHES CERCLAGE POSITIONING PIN (K992891)Synthes (Usa)1999-11-02
MASS (MICRO-ACCESS SPINE SYSTEM) (K992583)Omni-Tract Surgical, Div. Minn. Scientific, Inc.1999-10-29
ROTORBLADE SUTURE ANCHOR (K993373)Li Medical Technologies, Inc.1999-10-27
ZMR HIP SYSTEM-REVISION TAPER (K992667)Zimmer, Inc.1999-10-27
SDB CERCLAGE SYSTEM (K992616)Pioneer Surgical Technology1999-10-27
HEX BUTTON (K992617)Pioneer Surgical Technology1999-10-27
NEXT GENERATION RODDING SYSTEM (K992784)United States Surgical, A Division of Tyco Healthc1999-10-27
FLEXIBLE FIBERSCOPES & ACCESSORIES (K990397)Richard Wolf Medical Instruments Corp.1999-10-25
3.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM 90 CANNULATED LC-ABP) (K992837)Synthes (Usa)1999-10-25
HYDROCISION ARTHROJET SYSTEM WITH CAUTERY (K993009)Hydrocision, Inc.1999-10-25
REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS (K991026)Smith & Nephew, Inc.1999-10-22
HOWMEDICA OSTEONICS ACCP SYSTEM CORTICAL SCREWS (K993181)Howmedica Osteonics Corp.1999-10-22
BIO-MODULAR SHOULDER OFFSET HUMERAL HEADS (K992899)Biomet, Inc.1999-10-21
BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT (K992394)Endotec, Inc.1999-10-15
CONTOUR SPINAL SYSTEM (K990986)Ortho Development Corp.1999-10-14
RC MULTISUTURE BONE ANCHOR, MODEL 4453/4454 (K992458)Innovasive Devices, Inc.1999-10-14
MAXIM KNEE SYSTEM (K993159)Biomet, Inc.1999-10-14
SYNERGY INTEGRAL SCREWS, MODELS, 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220,2221,22 (K992369)Interpore Cross Intl.1999-10-13
HOWMEDICA OSTEONICS RESTORATION HA HIP STEM (K993077)Howmedica Osteonics Corp.1999-10-08
RC TACK (K992377)Innovasive Devices, Inc.1999-10-08
EBI OMEGA 21 SYSTEM (K992333)Electro-Biology, Inc.1999-10-08
THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2YY-ZZZZ (K992409)Implex Corp.1999-10-08
MODIFICATION TO BONE MULCH SCREW SYSTEM (K993025)Biomet, Inc.1999-10-08
ALTA FULLY THREADED CROSS-LOCKING 5.0 MM SCREW (K993004)Howmedica Osteonics Corp.1999-10-06
NUVASIVE SPINAL ARTHROSCOPE, MODELS 0, 30 AND 70 DEGREES (K992782)Nuvasive, Inc.1999-10-05
ASCENT KNEE SYSTEM (K993111)Biomet Manufacturing, Inc.1999-10-05
NUVASIVE GUIDED SPINAL ARTHROSCOPY SYSTEM (K990324)Nuvasive, Inc.1999-10-05
MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM (K992276)Sulzer Spine-Tech1999-10-01
VAPR 2.3 MM SIDE EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM (K992876)Mitek Products1999-09-24
ARTHROSCOPE / MEDIFIX INC. (K992474)Medifix, Inc.1999-09-23
EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS (K992367)Electro-Biology, Inc.1999-09-23
ROTORBLADE SUTURE ANCHOR (K992938)Li Medical Technologies, Inc.1999-09-23
SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN) (K992348)Synthes (Usa)1999-09-23
MOSS MIAMI 6.35MM POLYAXIAL SCREW (K992168)Depuyacromed1999-09-23
PE-PLUS ACETABULAR CUP (K992153)Plus Orthopedics1999-09-23
MITEK ROTATOR CUFF QUICKANCHOR PLUS (K992611)Mitek Products1999-09-22
BIOPRO RIMMED ACETABULAR COMPOMENT (K992144)Biologically Oriented Prostheses1999-09-22
PYLON INTRAMEDULLAARY NAIL SYSTEM (K992350)Alphatec Mfg., Inc.1999-09-22
MITEK MINI QUICKANCHOR PLUS (K992487)Mitek Products1999-09-21
CD HORIZON SPINAL SYSTEM (K992928)Sofamor Danek USA,Inc.1999-09-21
CANNULATED SMARTSCREW MODELS 224540C, 224570C (K992947)Bionx Implants, Ltd.1999-09-21
BIOBUTTON (K990194)Linvatec Corp.1999-09-17
MODUS SYSTEM SELF-DRILLING SCREWS (K992106)Medartis AG1999-09-17
COLOR BUFFED CEMENTED FEMORAL (K992903)Biomet, Inc.1999-09-17
PREMIER ANTERIOR CERVICAL PLATE SYSTEM (K992110)Sofamor Danek USA1999-09-14
DANEK PLATE AND SCREW SYSTEM (K991036)Sofamor Danek USA,Inc.1999-09-14
BIO-MODULAR SHOULDER SYSTEM (K992119)Biomet, Inc.1999-09-13
TRI-POLAR SYSTEM (K991990)Biomet, Inc.1999-09-10
OSTEO IC FEMORAL AND TIBIAL NAILS IN TITANIUM ALLOY (K992063)Howmedica Osteonics Corp.1999-09-03
MODULAR RADIAL HEAD (K991915)Wrightmedicaltechnologyinc1999-09-03
STACKABLE CAGE SYSTEM (K990148)Depuy Motech Acromed1999-09-03
UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE (K992570)Howmedica Osteonics Corp.1999-09-01
REUNITE SCREWS (K992301)Biomet Manufacturing, Inc.1999-09-01
DYNA-LOK PLUS SPINAL SYSTEM (K991198)Sofamor Danek USA,Inc.1999-08-27
ANATOMICAL BANKART TACK, MODEL 523520A (K992567)Bionx Implants, Ltd.1999-08-27
PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA) (K990261)Plus Orthopedics1999-08-27
OSTEONICS SPINAL SYSTEM- ROD/ PLATE SYSTEM (K991055)Howmedica Osteonics Corp.1999-08-27
SYNTHES CERVIFIX SYSTEM (K991089)Synthes Spine1999-08-27
OSTEOPLAST, MODEL POP200 (K991854)Interpore Cross Intl.1999-08-26
AEQUALIS SHOULDER PROSTHESIS (K980244)Tornier1999-08-23
EBI XFIX DFS RAIL SYSTEM (K991941)Electro-Biology, Inc.1999-08-19
B2C HIP SYSTEM (K992490)Lepine Groupe Spa.1999-08-19
BIPOLAR SHOULDER PROSTHESIS (K991585)Biomet, Inc.1999-08-18
EBI XFIX DFS OPTIROM ELBOW FIXATOR (K992515)Ebi, L.P.1999-08-17
MAXIM REMOVABLE MOLDED POLY TIBIA (K991753)Biomet, Inc.1999-08-17
KMI WRIST FUSION SYSTEM (K991873)Kinetikos Medical, Inc.1999-08-17
ENDOSCOPIC SPINAL ACCESS SYSTEM (K991794)Endius, Inc.1999-08-13
PRECISION OSTEOLOCK FEMORAL STEMS WITH PURE-FIX HA COATING (K992025)Howmedica Osteonics Corp.1999-08-13
ARTHREX MENISCAL DART SYSTEM (K983577)Arthrex, Inc.1999-08-13
EBI OMEGA 21 SYSTEM (K991721)Ebi Electro Biology1999-08-13
ENCORE FULLY COATED HIP (K992109)Encore Orthopedics, Inc.1999-08-12
KINEMATIC II ROTATING HINGE KNEE (K992346)Howmedica Osteonics Corp.1999-08-12
ULTIMAX HAIG II NAIL SYSTEM (K991889)Encore Orthopedics, Inc.1999-08-12
WHITESIDE BIOMECHANICS SPINAL SYSTEM (K991678)Whiteside Biomechanics, Inc.1999-08-12
RIWO DRIVE GENERATOR (K984304)Richard Wolf Medical Instruments Corp.1999-08-12
BIOSTINGER-V BIOABSORBABLE MENISCAL REPAIR DEVICE (K991715)Linvatec Corp.1999-08-06
FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES (K992040)Fiber Imaging Technologies, Inc.1999-08-06
HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA) REFLECTION INTERFIT SHELL (K990666)Smith & Nephew, Inc.1999-08-06
MACMED PAEDIATRIC INTRAMEDULLARY NAIL (K991877)Innervision, Inc.1999-08-06
VHS SUPRACONDYLAR PLATE SYSTEM (K991806)Walter Abendschein, M.D.1999-08-06
ULTIMAX ANKLE FUSION ROD SYSTEM (K991790)Encore Orthopedics, Inc.1999-08-06
INTER-OP METASUL ACETABULAR SYSTEM (K974728)Sulzer Orthopedics, Inc.1999-08-03
SOLUSTAPLE (K991566)New Deal, S.A.1999-08-03
STAPLETAC BONE ANCHOR SYSTEM (K992277)Influence, Inc.1999-07-30
LACTOSORB HAND SYSTEM (K991763)Biomet, Inc.1999-07-30
NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE CO (K991581)Zimmer, Inc.1999-07-30
UC-PLUS SOLUTION UNICONDYLAR KNEE SYSTEM (K982859)Plus Orthopedics1999-07-30
AGC V2 REVISION KNEE SYSTEM (K984054)Biomet, Inc.1999-07-30
ZIRCONIA 22.22MM CERAMIC MODULAR HEADS (K991708)Biomet, Inc.1999-07-30
BIORC ANCHOR (K990770)Linvatec Corp.1999-07-30
OSTEONICS ACCP SYSTEM LINE EXTENSION (K992344)Howmedica Osteonics Corp.1999-07-30
PERFORMANCE KNEE SYSTEM (K992167)Biomet, Inc.1999-07-28
SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) (K991586)Osteotech, Inc.1999-07-23
OSTEONICS HA-COATED DEVICES (K980070)Osteonics Corp.1999-07-23
TRANSFX MULTI PIN CLAMP (K991723)Immedica, Inc.1999-07-22
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