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Orthopedic

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

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RecordFirmDate
NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR)-FLEX FEMORAL COMPONENTS (K023211)Zimmer, Inc.2002-10-17
OPTETRAK TOTAL KNEE SYSTEM OFFSET TIBIAL TRAY (K023186)Exactech, Inc.2002-10-17
BOSWORTH CORACO-CLAVICULAR SCREW (K023294)Howmedica Osteonics Corp.2002-10-09
ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM (K023102)Howmedica Osteonics Corp.2002-10-09
JET-X TIN COATED HALF PINS (K023134)Smith & Nephew, Inc.2002-10-09
SMITH & NEPHEW SURETAC - EXPANDED INDICATIONS II (K020948)Smith & Nephew, Inc.2002-10-09
AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM (K022207)Axya Medical, Inc.2002-10-04
NUGEN FX SCREW (K023022)Bionx Implants, Inc.2002-10-04
RHS ACETABULAR COMPONENT (K022382)Signal Medical Corp.2002-10-04
MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T (K023021)Smith & Nephew, Inc.2002-10-04
CLASSIC GREAT TOE IMPLANT (K023086)Nexa Orthopedics, Inc.2002-10-04
ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322B (K022234)Arthrex, Inc.2002-10-03
PROXILOCK HIP PROSTHESIS; SIZE 12/36 (K022966)Implex Corp.2002-10-02
ENDIUS ATAVI SYSTEM (K022199)Endius, Inc.2002-10-02
TOTAL HIP FEMORAL HEADS AND LINERS (K022958)Smith & Nephew, Inc.2002-10-02
SMITH & NEPHEW HIP SYSTEM (K022902)Smith & Nephew, Inc.2002-10-02
AXIAMED TRANS-SACRAL SPINAL ACCESS DEVICE (K020457)Axiamed, Inc.2002-09-26
TRINICA SELECT ANTERIOR CERVICAL PLATE SYSTEM (K022344)Centerpulse Spine-Tech, Inc.2002-09-24
CADENCE SPINAL FIXATION SYSTEM (K022374)Sulzer Spine-Tech2002-09-24
SHORT AND LONG SOFT TISSUE ATTACHMENT (K022079)Biomet, Inc.2002-09-24
PLUS PIVOT LINK UNIVERSAL SYSTEM (K022271)Spine Vision, Inc.2002-09-23
ORTHOGUARD AB ANTIMICROBIAL SLEEVE (K022676)Smith & Nephew, Inc.2002-09-23
TWIN FIX (K022771)Fixano SA2002-09-23
RESTORATION MODULAR SYSTEM (K022549)Howmedica Osteonics Corp.2002-09-23
TOTAL KNEE CEMENTED, SEMI-CONSTRAINED (K021740)Dj Orthopedics, LLC2002-09-23
SIGN IM NAIL (K022632)Surgical Implant Generation Network (Sign)2002-09-23
HIP TOOL IMPLANT (K022139)Orthopedic Sciences, Inc.2002-09-23
MODIFICATION TO TSRH SPINAL SYSTEM (K022778)Medtronic Sofamor Danek, Inc.2002-09-18
BIOMET CALCANEAL PLATE (K022515)Biomet Orthopedics, Inc.2002-09-17
PREMIER ANTERIOR CERVICAL PLATE SYSTEM (K021761)Medtronic Sofamor Danek2002-09-17
EXTERNAL FIXATION RING (K022423)Rigid FX Orthopedics, Incorporated2002-09-17
NORMED TITANIUM CALCANEUS PLATING WITH LOCKING SCREW SYSTEM (K022324)Osteomedics, Inc.2002-09-17
NORMED DISTAL RADIUS RECONSTRUCTION SYSTEM (K022231)Osteomedics, Inc.2002-09-13
INION CPS 2.5/2.8 SCREW (K022981)Inion , Ltd.2002-09-12
NORMED MINI EXTERNAL FIXATOR SYSTEM (K022230)Osteomedics, Inc.2002-09-10
UCR SPINAL SYSTEM, 5.5MM, 8.0MM SCREWS & INSTRUMENTS (K021623)Iame, Inc.2002-09-10
NORMED TITANIUM RONDO FIX FUSION PLATES AND SCREW SYSTEM (K022323)Osteomedics, Inc.2002-09-09
NORMED TITANIUM OSTEOTOMY PLATING SYSTEM (K022325)Osteomedics, Inc.2002-09-09
STAYFUSE GT-IP (K022726)Pioneer Surgical Technology2002-09-06
ARTHREX UNIVERS FRACTURE PROSTHESIS (K020345)Arthrex, Inc.2002-09-06
SYNTHES 6.5 MM CANNULATED SCREW (K021932)Synthes (Usa)2002-09-06
CALCIUM PHOSPHATE GRANULAR BONE VOID FILLER (K011531)Biomet, Inc.2002-09-06
HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, MODEL 7.3MM (K022647)Triad Medical, Inc.2002-09-05
ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM (K021891)Zimmer, Inc.2002-09-05
HYDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1 (K022563)Implex Corp.2002-08-30
MODIFICATION TO TENOR SPINAL SYSTEM (K022191)Medtronic Sofamor Danek, Inc.2002-08-28
REFLECTION MODIFIED ACETABULAR SHELLS (K022556)Smith & Nephew, Inc.2002-08-28
5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM) (K022623)Depuyacromed2002-08-27
VERTE-STACK SPINAL SYSTEM (K021791)Medtronic Sofamor Danek2002-08-26
TEMPFIX EXTERNAL FIXATION SYSTEM (K021933)DePuy Orthopaedics, Inc.2002-08-26
BNF (K021782)Aap Implantate AG2002-08-26
MODIFICATION TO AVALON CUP SYSTEM (K022711)Orthopedic Source, Inc.2002-08-26
TITANIUM ANKLE ARTHRODESIS NAIL (K021786)Biomet, Inc.2002-08-26
2MM PEDIATRIC FLEX NAIL (K022531)Biomet, Inc.2002-08-26
S2 TIBIAL NAIL (K022481)Howmedica Osteonics Corp.2002-08-26
ACCOLADE C FEMORAL STEMS (K022555)Howmedica Osteonics Corp.2002-08-26
ENDIUS FLEXTIP BLADE (K022578)Endius, Inc.2002-08-23
UNI KNEE (K022437)Encore Medical L.P.2002-08-23
S2 FEMORAL NAIL (K022461)Howmedica Osteonics2002-08-22
BLACKSTONE SPINAL FIXATION SYSTEM STAPLE & WASHER (K022605)Blackstone Medical, Inc.2002-08-21
TOTAL KNEE FEMORAL COMPONENT (K022010)Smith & Nephew, Inc.2002-08-19
HA MODULAR REACH PROXIMAL POROUS AND HA MODULAR REACH COLLARED PROXIMAL POROUS FEMORAL STEMS (K022463)Biomet Orthopedics, Inc.2002-08-16
ANTERIOR STABILIZED TIBIAL BEARINGS (K022586)Biomet Orthopedics, Inc.2002-08-15
MODIFICATION TO ISOLA SPINAL SYSTEM (K022285)Depuyacromed2002-08-13
EBI DYNAFIX VS OSTEOTOMY SYSTEM (K021749)Ebi, L.P.2002-08-12
MAGLY 6.5MM CANNULATED SCREWS (K021662)Magly Orthopedics, LLC2002-08-12
HALLU PLATES (K021626)New Deal, S.A.2002-08-12
EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM (K022419)Ebi, L.P.2002-08-12
UKNEE TOTAL KNEE SYSTEM (K021657)United Orthopedic Corp.2002-08-12
EBI XFIX DFS SYSTEM (K022319)Ebi, L.P.2002-08-12
SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW (K021556)Synthes (Usa)2002-08-09
NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE (K021578)Sulzer Orthopedics, Inc.2002-08-09
MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM (K021579)Magly Orthopedics, LLC2002-08-09
SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X (K022065)Sintea Biotech, Inc.2002-08-06
BLACKSTONE SPINAL FIXATION SYSTEM SPACER (K022399)Blackstone Medical, Inc.2002-08-06
CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM (K021549)Std Mfg., Inc.2002-08-01
XIA SPINAL SYSTEM (K022160)Howmedica Osteonics2002-08-01
PLUS PIVOT LINK UNIVERSAL SYSTEM (K021507)Spine Vision, Inc.2002-08-01
UNI-T UNI-THREAD SPINAL SYSTEM (K021510)Spine Vision, Inc.2002-08-01
EPOCH HIP PROSTHESIS, MODEL 4075 SERIES (K014070)Zimmer, Inc.2002-07-30
WISORB MALLEOLAR SCREW (K020222)Cambridge Scientific, Inc.2002-07-29
ENDIUS TITLE SPINAL FIXATION SYSTEM (K021881)Endius, Inc.2002-07-29
MODOFOCATION TO SYNTHES ANKLE ARTHRODESIS PLATES (K022255)Synthes (Usa)2002-07-25
NOVABONE-RESORBABLE BONE GRAFT SUBSTITUTE (K021336)Novabone Products, LLC2002-07-25
VECTOR MEDICAL, INC., VECTOR TARGETING SYSTEM (K022225)Vector Medical, Inc.2002-07-25
PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING (K022094)Biomet, Inc.2002-07-25
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K021061)Medtronic Sofamor Danek2002-07-25
36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT) (K022077)Howmedica Osteonics Corp.2002-07-25
CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 BONE CEMENT (K021499)DePuy Orthopaedics, Inc.2002-07-24
SYNTHES IN-SITU BENDER/CUTTER (K021458)Synthes (Usa)2002-07-24
MPF ACETABULAR CUP GENERATION 2 (K022120)Plus Orthopedics2002-07-24
CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE (K021466)Hayes Medical, Inc.2002-07-24
MODIFICATION TO SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM (K022190)Depuyacromed2002-07-24
R120 MODULAR TOTAL HIP SYSTEM (K021822)Osteoimplant Technology, Inc.2002-07-23
ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM (K020356)Alphatec Mfg., Inc.2002-07-23
SEARCH EVOLUTION TOTAL KNEE SYSTEM (K021313)Aesculap, Inc.2002-07-22
OPUS MAGNUM ANCHOR & INSTRUMENT SET (K020172)Opus Medical, Inc.2002-07-22
ATLANTIS VISION ANTERIOR CERVICAL PLATE SYSTEM (K021461)Medtronic Sofamor Danek2002-07-22
MASTERGRAFT RESORBABLE CERAMIC (K020986)Medtronic Sofamor Danek, Inc.2002-07-22
COLORADO 2 SPINAL SYSTEM (K020247)Medtronic Sofamor Danek, Inc.2002-07-22
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