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Orthopedic

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

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RecordFirmDate
POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM (K100438)Ebi, L.P.2010-06-23
ACL TIGHTROPE (K100652)Arthrex, Inc.2010-06-23
POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEM (K100409)Biomet Spine (Aka Ebi, LLC)2010-06-23
DYNA LOCKING TROCHANTERIC NAIL, MODEL NG0820 (K093707)U&I Corp.2010-06-23
APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD (K101451)Omni Life Science, Inc.2010-06-22
MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEM (K101074)Medtronic Sofamor Danek USA, Inc.2010-06-22
QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM) (K100497)N.M.B. Medical Applications, Ltd.2010-06-21
OPUS SPEEDSCREW SYSTEM (K101448)Arthrocare Corp.2010-06-21
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM (K100685)Alphatec Spine, Inc.2010-06-18
MOTIVATION KNEE SYSTEM (K100900)Encore Medical L.P.2010-06-18
COMPRESS ANTI-ROTATION SPINDLES (K101475)Biomet Manufacturing Corp2010-06-18
T2 GREATER TROCHANTER NAIL (K101438)Howmedica Osteonics Corp.2010-06-17
COROENT XLR STANDALONE SYSTEM (K100043)Nuvasive, Inc.2010-06-16
ASCENSION ANKLE FUSION PLATE SYSTEM (K100176)Ascension Orthopedics, Inc.2010-06-16
MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OLECRANON PLATES MODEL 131218704-708; 851318704-708, 131218204 (K101421)DePuy Orthopaedics, Inc.2010-06-15
UNITED STEM, PSA TYPE (K100981)United Orthopedic Corp.2010-06-14
OTIS -C PLUS (K100604)Sciences ET Bio Materiaux (Sbm)2010-06-14
G-FORCE PEEK SUTURE ANCHOR SYSTEM (K100630)Wrightmedicaltechnologyinc2010-06-11
SIDEKICK CIRCULAR FIXATOR SYSTEM: STRUTS AND HINGES (K100137)Wrightmedicaltechnologyinc2010-06-10
GUIDED GROWTH SYSTEM (K093442)Orthofix, Inc.2010-06-10
AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEM (K100623)Aesculap Implant Systems2010-06-09
MIS SYSTEM (K100605)Spine Wave, Inc.2010-06-04
PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES (K100708)Pioneer Surgical Technology2010-06-04
MODIFICATION TO HBS HEADLESS BONE SCREW (K101030)Biopro, Inc.2010-06-03
CLYDESDALE SPINAL SYSTEM (K100175)Medtronic Sofamor Danek2010-06-02
SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX (K092608)Collagen Matrix, Inc.2010-05-28
APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM) (K100151)Omnlife Science2010-05-28
EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM 36MM GLENOSPHERE AND HUMERAL LINER (K093275)Exactech, Inc.2010-05-27
FUSION MEDICAL RING LOCK SYSTEM (K100857)John J Riccio2010-05-27
NOVATION CROWN CUP GXL LINERS (K100269)Exactech, Inc.2010-05-27
PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES (K093405)Wrightmedicaltechnologyinc2010-05-25
MAMBO, MODEL CS 18XX-XX (K090861)Ulrich GmbH & Co. KG2010-05-21
BIOMET FORERUNNER LOCKING PLATE SYSTEM (K092528)Biomet Trauma (Aka Ebi, Lp)2010-05-21
TRANSCORP TRANS-PLATE ANTERIOR CERVICAL PLATE SYSTEM (K092695)Transcorp, Inc.2010-05-21
KFX APPIANFX PEEK FEMORAL IMPLANT WITH INSERTER (K101175)Kfx Medical2010-05-20
SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115 (K093820)Memometal Technologies2010-05-19
IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF (K083798)Medicrea Technologies2010-05-19
REGENT ANTERIOR CERVICAL PLATE (K101151)Custom Spine2010-05-19
TITAN TI SUTURE ANCHOR SYSTEM, MODELS 22-9055, 22-9055N, 22-9065, 22-9065N, 22-9022, 22-9005,, 22-9006 (K101184)Arthrocare Corp.2010-05-18
CARDO MEDICAL CERAMIC HIP SYSTEM (K100008)Cardo Medical, Inc.2010-05-18
POLARIS SPINAL SYSTEM (K100220)Ebi, L.P.2010-05-17
ORTHOPEDIATRICS PEDILOC TIBIA PLATE SYSTEM (K100240)OrthoPediatrics Corp.2010-05-17
COCR RODS (K100788)Globus Medical, Inc.2010-05-14
VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES (K100271)Howmedica Osteonics Corp.2010-05-14
VARIAX ELBOW SYSTEM (K101056)Howmedica Osteonics Corp.2010-05-13
LEGION POROUS + HA TIBIAL BASEPLATES (K100897)Smith & Nephew, Inc.2010-05-13
DIAMOND ANTERIOR CERVICAL PLATE SYSTEM (K100265)Amendia, Inc.2010-05-13
SYNTHES T-PAL SPACER (K100089)Synthes Spine2010-05-13
SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS (K092190)Synthes (Usa)2010-05-11
EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM (K093978)Exactech, Inc.2010-05-11
SYNTHES (USA) 2.7MM/ 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PLATES (K092812)Synthes (Usa)2010-05-11
HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM (K100238)DePuy Orthopaedics, Inc.2010-05-11
SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM (K094002)Spartek Medical, Inc.2010-05-07
AEQUALIS REVERSED SHOULDER PROSTHESIS (K100142)Tornier2010-05-06
BIOLOX DELTA CERAMIC FEMORAL HEADS (K100412)Smith & Nephew, Inc.2010-05-05
PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES (K100325)Smith & Nephew, Inc.2010-05-04
HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES (K100614)Blackstone Medical, Inc.2010-05-04
GRYPHON T BR DS ANCHOR W/ORTHOCORD, GRYPHON T BR ANCHOR W /ORTHOCORD, GRYPHON P BR DS ANCHOR W/ORTHOCORD, GRYPHON P BR A (K100012)Depuy Mitek, A Johnson & Johnson Company2010-04-30
TSRH SPINAL SYSTEM (K091797)Medtronic Sofamor Danek2010-04-30
RINGLOC + HYBRID ACETABULAR SYSTEM (K093235)Biomet, Inc.2010-04-30
AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 5MM LOCKING INSERTS (K100475)Howmedica Osteonics Corp.2010-04-30
PROFEMUR HIP SYSTEM MODULAR NECKS (K100866)Wrightmedicaltechnologyinc2010-04-28
ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM (K093561)Zimmer, Inc.2010-04-28
EXTREMITY MEDICAL SCREW SYSTEM (K093770)Extremity Medical, LLC2010-04-28
PIEZOELECTRIC SYSTEM (K100410)Satelec2010-04-28
EPICAGE INTERBODY FUSION DEVICE (K092901)R Tree Innovations2010-04-28
CRESCENT SPINAL SYSTEM (K094025)Medtronic Sofamor Danek2010-04-26
ENDURAMESH, MODEL 762.XXX (K093207)Lucero Medical, LLC2010-04-26
SURESHOT TAN NAILS AND ACCESSORIES (K092748)Smith & Nephew, Inc.2010-04-26
NANOSS BONE VOID FILLER (K100361)Pioneer Surgical Technology2010-04-22
DIAMONDBACK SPINAL SYSTEM (K100377)Eminent Spine2010-04-22
GRAFTY QUICKSET (K093343)Graftys2010-04-22
MODIFICAITON TO: CARDO MEDICAL HIP SYSTEM (K094045)Cardo Medical Corp.2010-04-22
SMITH & NEPHEW HIP SYSTEMS WITH HA (K090982)Smith & Nephew, Inc.2010-04-21
MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY (K100618)Orthohelix Surgical Designs, Inc.2010-04-20
DISTALOCK FEMORAL INTRAMEDULLARY NAIL SYSTEM (K100312)Dgimed Ortho, Inc.2010-04-20
SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR (K100159)Smith & Nephew Inc., Endoscopy Div.2010-04-19
PEANUT GROWTH CONTROL PLATING SYSTEM (K093880)Ebi, L.P.2010-04-16
SLR-PLUS STANDARD AND LATERAL FEMORAL STEMS (K093991)Smith & Nephew, Inc.2010-04-15
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) (K100191)Lanx, Inc.2010-04-15
CORMET CEMENTLESS RESURFACING FEMORAL HEAD (K092198)Corin USA2010-04-15
VERILAST WEAR CLAIMS FOR THE LEGION PRIMARY KNEE SYSTEM (K093746)Smith & Nephew, Inc.2010-04-14
ZUMA-C (K092521)Seaspine, Inc.2010-04-13
MODIFICATION TO: TRIO+SPINAL FIXATION SYSTEM (K100737)Stryker Spine2010-04-12
DEROYAL NON-LOCKING BONE FIXATION SYSTEM (K090975)Deroyal Industries, Inc.2010-04-12
NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM (K100111)Zimmer, Inc.2010-04-12
SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALL (K100676)Synthes (Usa)2010-04-08
MYKNEE CUTTING BLOCKS (K093806)Medacta International S.A.2010-04-08
APEX ARC HIP STEM (K090845)Omni Life Science, Inc.2010-04-07
ARCHIMED REMEDY CERVICAL PLATE (K100215)Archimed, Inc.2010-04-07
LANX ANTERIOR PLATING SYSTEM (K092765)Lanx, Inc.2010-04-07
SMITH & NEPHEW FOOTPRINT RCX PK SUTURE ANCHOR (K093935)Smith & Nephew, Inc.2010-04-05
MINIHIP STEM (K083312)Corin USA2010-04-05
AEGIS & AEGIS II SPINAL SYSTEM (K092076)Corentec Co., Ltd.2010-04-02
STRYKER SONICPIN SYSTEM (K091955)Howmedica Osteonics Corp.2010-04-02
SMITH & NEPHEW TWINFIX ULTRA HA SUTURE ANCHOR (K093844)Smith & Nephew, Inc.2010-04-01
LDR SPINE USA SPINE TUNE TL SPINE SYSTEM (K100575)Ldr Spine USA2010-03-31
SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES (K093928)Synthes (Usa)2010-03-29
SYNTHES STERNAL FIXATION SYSTEM (K093772)Synthes2010-03-29
APEX-LNK ACETABULAR INSERT, E, APEX-LNK ACETABULAR INSERT, F, APEX-LNK (K100555)Omni Life Science, Inc.2010-03-29
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