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Orthopedic

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

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RecordFirmDate
HELICON HIP SYSTEM, FEMORAL STEM, HELICON HIP SYSTEM, FEMORAL HEAD, COCR, HELICON HIP SYSTEM, ACETABULAR SHELL, HELICON (K111472)Tgm Medical2011-09-06
MICROSUTURE ANCHORS (K112237)Arthrex, Inc.2011-09-02
BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION (K110791)Zimmer, Inc.2011-09-02
CAPSURE(R) PS SYSTEM (K111913)Spine Wave, Inc.2011-08-31
CMC CABLE FIX (K111032)Instratek, Inc.2011-08-31
DEPUY STTUNE (TM) PS KNEE SYSTEM (K111433)DePuy Orthopaedics, Inc.2011-08-30
TSRH SPINAL SYSTEMS (K111942)Medtronic Sofamor Danek USA, Inc.2011-08-30
NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODEL (K111572)Serf2011-08-29
SLIC SCREW REPAIR SYSTEM (K111608)Acumed, LLC2011-08-29
INQU PASTE MIX PLUS (K103799)Isto Technologies, Inc.2011-08-29
INSTINCT JAVA SYSTEM (K111301)Zimmer Spine2011-08-26
DAYTONA ANTERIOR CERVICAL CAGE (K110733)Spinenet, LLC2011-08-25
CHESAPEAKE (CERVICAL COMPONENTS) (K111439)K2m, Inc.2011-08-24
PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES (K111528)Pioneer Surgical Technology, Inc.2011-08-24
PERIMETER INTERBODY FUSION DEVICE (K111525)Medtronic Sofamor Danek2011-08-24
PASS ANTERIOR SPINAL SYSTEM (K102406)Medicrea Technologies2011-08-23
STREAMLINE TL SPINAL SYSTEM (K111502)Pioneer Surgical Technology, Inc.2011-08-23
SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICS (K111620)Skeletal Dynamics, LLC2011-08-23
TALON DISTALFIX PROXIMAL FEMORAL NAIL (K111352)Orthopedic Designs North America, Inc.2011-08-22
PROFEMUR(R) E CEMENTLESS HIP STEM (K111698)Wrightmedicaltechnologyinc2011-08-19
SONOMA FASTRAC CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA FASTRAC XXYYY(X=DIA, YYY=LENGTH- IN MM) (K111550)Sonoma Orthopedic Products, Inc.2011-08-19
TRIMED RADIOCARPAL FUSION SYSTEM (K102785)TriMed, Inc.2011-08-19
POLARIS SPINAL SYSTEM (K111957)Biomet Spine (Ebi, LLC)2011-08-19
STAXX XDL SYSTEM (K102315)Spine Wave, Inc.2011-08-19
ARTHREX SCAPHOLUNATE ANCHOR (K111661)Arthrex, Inc.2011-08-19
EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R) TRIAD (TM) BONE SCREWS (K111432)Wrightmedicaltechnologyinc2011-08-19
BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR (K110879)Biomet Sports Medicine2011-08-19
NUGAIT(TM) SUBTALAR IMPLANT SYSTEM (K111799)Ascension Orthopedic2011-08-19
PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM (K111699)Wrightmedicaltechnologyinc2011-08-19
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM (K112108)Spineart2011-08-19
SMR REVERSE SHOULDER SYSTEM (K110598)Lima Corporate S.P.A.2011-08-18
PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES) (K111135)K2m, Inc.2011-08-17
REVOLVE ADDITIONAL IMPLANTS (K111449)Globus Medical, Inc.2011-08-17
REVERE CROSSTOP (K111479)Globus Medical, Inc.2011-08-17
TRUMATCH PERSONALIZED SOLUTIONS (K110397)DePuy Orthopaedics, Inc.2011-08-16
ENDO HEAD (K111145)Medacta International2011-08-16
UNIVERSAL CLAMP SPINAL FIXATION SYSTEM (K110348)Zimmer Spine2011-08-11
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM (K111127)Spineart2011-08-11
SYNTHES RIA SYSTEM (EXPANDED INDICATIONS) (K111437)Synthes (USA) Products, LLC2011-08-10
SPEEDLOCK KNOTLESS FIXATION DEVICE; 3.0MM DRILL; SHARP TIPPED OBTURATOR; LOW PROFILE DRILL GUIDDE (K111044)ArthroCare Corporation2011-08-09
CRESCENT (R) SPINAL SYSTEM TITANIUM (K110543)Medtronic Sofamor Danek USA, Inc.2011-08-09
METASURG SUBTALAR IMPLANT (K111265)Metasurg2011-08-09
SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM (K111540)Synthes (Usa)2011-08-08
Y-KNOT ALL-SUTURE ANCHOR MODEL HF13 (K111779)Conmed Linvatec2011-08-08
T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP (K112059)Stryker2011-08-08
ROG SUTURE ANCHOR, ROG KNOTLESS SUTURE ANCHOR (K111590)Rog Sports Medicine, Inc.2011-08-08
PERIMETER C SPINAL SYSTEM (K100967)Medtronic Sofamor Danek USA, Inc.2011-08-05
ORTHOPEDIATRICS BLADE PLATE SYSTEM (K110959)OrthoPediatrics Corp.2011-08-05
CORIN OPTIMOM MODULAR HEAD (K111911)Corin USA2011-08-04
AESCULAP SIBD XP SPINAL SYSTEM (K111122)Aesculap Implant Systems, Inc.2011-08-04
STRYKER SPINE POWER ADAPTOR (ACCESSORY INSTRUMENT) (K111478)Stryker Corporation2011-08-04
UNITED UTF STEM (K110245)United Orthopedic Corporation2011-08-04
CONSTRUX EXTERNAL FIXATION DEVICE (K111376)Ebi, LLC2011-08-03
DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000 (K101934)Medshape Solutions2011-08-03
VU C*POD INTERVERTEBRAL BODY FUSION DEVICE (K111675)Theken Spine, LLC2011-08-02
DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM (K110679)Phygen, LLC2011-08-02
ARTHREX DISTAL EXTREMITY PLATE SYSTEM (K111253)Arthrex, Inc.2011-08-02
MESA SPINAL SYSTEM (KEYSTONE RODS) (K110991)K2m, Inc.2011-08-02
LO-BAK TRAX (K110858)Roland F Berthiaume, DC2011-08-02
UNITED U2 XPE TOTAL KNEE SYSTEM (K103733)United Orthopedic Corporation2011-08-02
SYNTHES STERNAL ZIPFIX SYSTEM (K110789)Synthes (Usa)2011-07-28
SMR SHOULDER SYSTEM- REVISION STEMS (K111212)Lima Corporate S.P.A.2011-07-28
N-FORCE FIXATION SYSTEM (K102528)Innovision, Inc.2011-07-28
OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENT (K111400)Exactech, Inc.2011-07-28
PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHOR (K111000)Parcus Medical, LLC2011-07-28
APEX SPINE SYSTEM (K110906)Spinecraft, LLC2011-07-26
GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM (K110990)Gold Standard Orthopedics, LLC2011-07-25
3.7MM/5.0MM DYNAMIC LOCKING SCREW (K110592)Synthes USA2011-07-25
VENUS CERVICAL SPINAL FIXATION SYSTEM (K103414)L&K BIOMED Co., Ltd.2011-07-22
MAESTRO WRIST PLATING SYSTEM (K110271)Biomet Manufacturing Corp2011-07-22
CERVICAL CAGE (K110915)Eisertech, LLC2011-07-22
NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM (K111866)Nuvasive, Inc.2011-07-22
GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED SUTURE ANCHOR, ROTATOR CUFF ANCHOR / ROTATOR CUFF QUICK AN.. (K111631)Depuy Mitek, A Johnson & Johnson Company2011-07-22
COREN TOTAL HIP SYSTEM (K103431)Corentec Co., Ltd.2011-07-21
EXPLOR RADIAL HEAD PLATING SYSTEM (K110201)Biomet, Inc.2011-07-21
REXIOUS SPINAL FIXATION SYSTEM (K111362)Dio Medical Co., Ltd.2011-07-21
DSC/ALF SPINAL SYSTEM (K101886)Sintea Plastek, LLC2011-07-21
SIMMETRY(TM) SACROILIAC JOINT FUSION SYSTEM (K111801)Zyga Technology, Inc.2011-07-21
GENESYS SPINE TILOCK SYSTEM (K103671)Genesys Spine2011-07-21
DEPUY MITEK MILAGRO INTERFERENCE SCREW MODEL 231803, 231804, 231807, 231809 (K103831)Depuy Mitek, A Johnson & Johnson Company2011-07-21
METASURG DIGIFUSE IMPLANT (K111536)Metasurg2011-07-21
COMPREHENSIVEPROXIMAL HUMERAL PLATING SYSTEM (K110320)Biomet Manufacturing Corp2011-07-21
ETURN SPINAL IMPLANT MODEL ETURN XX-12; ETURN XX-16 WHERE XX=07, 09, 11, 13, OR 15 AND ETURN XX-12 K; ETURN XX-16 K WHER (K100305)Icotec2011-07-21
REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP) (K111061)Encore Medical L.P.2011-07-20
SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75 (K111399)Arthrocare Corp.2011-07-20
PATHWAY MODEL 07XXXX (K111774)Custom Spine2011-07-20
AAP CANNULATED SCREWS (K111316)Aap Implantate AG2011-07-20
HEMI IMPLANT; MINI HEMI IMPLANT (K102401)Vilex, Inc.2011-07-20
PLATEAU SPACER SYSTEM (K111835)Life Spine, Inc.2011-07-19
STAXXSD SYSTEM (K111469)Spine Wave, Inc.2011-07-19
CAPSTONE R SPINAL SYSTEM (K103731)Medtronic Sofamor Danek2011-07-18
SMR SHOULDER SYSTEM - CTA HUMERAL HEADS (K110847)Lima Corporate S.P.A.2011-07-15
EXACTECH GIBRALT SPINAL SYSTEM (K110197)Exactech, Inc.2011-07-15
APEX KNEE SYSTEM, APEX ALL POLY TIBIA (K111062)Omni Life Science, Inc.2011-07-13
ATLAS SPINE PEDICLE SCREW SYSTEM (K110842)Atlas Spine, Inc.2011-07-13
ORTHOSORB RESORBABLE PINS (K111077)DePuy Orthopaedics, Inc.2011-07-12
ELLIPSE INTRAMEDULLARY LIMB LENGTHENING SYSTEM (K101997)Ellipse Technologies, Inc.2011-07-12
SOLANAS AVALON POSTERIOR FIXATION SYSTEM (K111076)Alphatec Spine, Inc.2011-07-12
TITAN TI SUTURE ANCHOR SYSTEM (K111397)Arthrocare Corp.2011-07-12
VLP FOOT TALUS PLATES, VLP PERCUTANEOUS CALCANEUS PLATES AND MISC VLP BONE SCREWS, PERI-LOC ANKLE FUSION PLATES (K110670)Smith & Nephew, Inc.2011-07-12
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