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Orthopedic

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

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RecordFirmDate
OMEGA 3 TROCHANTERIC STABILIZING PLATE (K081278)Howmedica Osteonics Corp.2008-05-29
REVERE UNIPLANAR SCREWS (K081195)Globus Medical, Inc.2008-05-28
ARCOFIX (K080020)Synthes Spine Co.Lp2008-05-23
SYNTHES 3.5 MM LCP DISTAL TIBIA T PLATES (K080522)Synthes (Usa)2008-05-23
APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES] (K080842)Omni Life Science, Inc.2008-05-23
SPACER-G TEMPORARY HIP PROSTHESIS (K062273)Tecres S.P.A.2008-05-22
SPACER-K TEMPORARY KNEE SPACER WITH GENTAMICIN, MODELS SPK0021, SPK0121, SPK0221, SPK0321 (K062274)Tecres S.P.A.2008-05-22
CONQUEST SPINAL SYSTEM (K080767)Life Spine2008-05-21
NOVEL SPINAL SPACER SYSTEM (K080699)Alphatec Spine, Inc.2008-05-21
MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM (K080029)Mako Surgical Corp.2008-05-16
ECHELON TITANIUM HIP SYSTEM (K072817)Smith & Nephew, Inc.2008-05-15
PROFEMUR LX 5/8 COATED HIP STEM (K081090)Wrightmedicaltechnologyinc2008-05-15
MODIFICATION TO VIPER SPINE SYSTEM (K073562)Depuy Spine, Inc.2008-05-15
PEEK PREVAIL CERVICAL INTERBODY DEVICE (K073285)Medtronic Sofamor Danek USA, Inc.2008-05-15
PLATEAU SPACER SYSTEM (K080411)Life Spine2008-05-15
SMARTSET GMV GENTAMICIN BONE CEMENT (K081163)DePuy Orthopaedics, Inc.2008-05-14
SMARTSET MV BONE CEMENT (K081155)DePuy Orthopaedics, Inc.2008-05-14
OSTEOTRANS-OT SCREW (K073312)Takiron Co., Ltd.2008-05-13
PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM (K073177)Pioneer Surgical Technology2008-05-13
OSTEOTRANS-OT PIN (K073311)Takiron Co., Ltd.2008-05-13
SPINAL USA INTERBODY FUSION DEVICE (K080314)Spinal USA2008-05-13
CONFORMIS TOTAL KNEE REPIAR SYSTEM (ITOTAL) TIBIAL COMPONENT: 6.0 MM THICKNESS (K080936)Conformis, Inc.2008-05-12
CAPSURE PS (R) SPINE SYSTEM (K081228)Spine Wave, Inc.2008-05-12
METHA SHORT STEM HIP SYSTEM (K080584)Aesculap Implant System, Inc.2008-05-09
SHELL CAGE, WAVE CAGE, LOOP CAGE (K080401)Advanced Medical Technologies AG2008-05-09
SMITH & NEPHEW MIS HIP STEM WITH STIKTITE (K080625)Smith & Nephew, Inc.2008-05-08
MODIFICATION TO EXPEDIUM SPINE SYSTEM (K080313)Depuy Spine, Inc.2008-05-08
LDR SPINE ROI-T IMPLANT (K080569)Ldr Spine USA2008-05-07
ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM (K081007)Zimmer, Inc.2008-05-06
AOS PROXIMAL HUMERAL PLATE (K080590)Advanced Orthopaedic Solutions, Inc.2008-05-06
EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS (K080980)Exactech, Inc.2008-05-06
NOVABONE PUTTY- BIOACTIVE SYNTHETIC GRAFT (K080009)Novabone Products, LLC2008-05-06
CAIS STAPLE (K073281)Depuy Mitek, A Johnson & Johnson Company2008-05-02
DSS STABILIZATION SYSTEM (K080963)Paradigm Spine2008-05-02
OSFERION (K080065)Olympus Terumo Biomaterials Corporation2008-05-02
C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM (K080646)Biomet Spine2008-05-02
PATHWAY (K080281)Custom Spine, Inc.2008-05-01
AESCULAP PEEK INTERVERTEBRAL BODY FUSION SYSTEM: A SPACE, CESPACE, PROSPACE, T-SPACE (K071983)Aesculap Implant Systems, Inc.2008-05-01
X-MESH EXPANDABLE CAGE SYSTEM (K080568)Depuy Spine, Inc.2008-05-01
SYNTHES 6.5MM MIDFOOT FUSION BOLT (K081071)Synthes (Usa)2008-05-01
XIA SPINAL SYSTEM, STAINLESS STEEL UNI-PLANAR SCREWS (K080928)Stryker Spine2008-04-30
MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR PLATE SYSTEM (K080429)Medtronic Sofamor Danek USA, Inc.2008-04-30
MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM (K080790)Theken Spine, LLC2008-04-29
CAP PLUS, EQUIVABONE, CAP/DBM (K080329)Etex Corp.2008-04-28
TRANS1 AXIALIF 2-LEVEL OR II SYSTEM (K073643)Trans1 Incorporated2008-04-28
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION (K080885)Medacta International S.A.2008-04-28
MANTA RAY ANTERIOR CERVICAL PLATE SYSTEM (K080690)Theken Spine, LLC2008-04-25
EXTERNAL FIXATION CLAMP 5.0 MM PIN X9.5MM ROD, MODEL 1151-100, EXTERNAL FIXATON CLAMP, 9.5MM ROD (K080408)Advanced Orthopaedic Solutions, Inc.2008-04-25
FOUNDATION CAGE (K073440)Corelink, LLC2008-04-24
CAPSTONE SPINAL SYSTEM (K073291)Medtronic Sofamor Danek USA, Inc.2008-04-24
TOSCA II ANTERIOR CERVICAL PLATE SYSTEM (K080815)Signus Medizintechnik GmbH2008-04-23
PLLA, HA SCREW (K080358)Smith & Nephew Inc., Endoscopy Div.2008-04-23
TORNIER CINCH KNOTLESS FIXATION IMPLANT SYSTEM (K080335)Tornier, Inc.2008-04-23
SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWS (K080943)Synthes (Usa)2008-04-23
PLEXUR-P (K080511)Osteotech, Inc.2008-04-21
REGENEREX TIBIAL COMPONENTS (K080361)Biomet, Inc.2008-04-21
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM (K080805)Medtronic Sofamor Danek2008-04-18
ISOBAR SEMI-RIGID DUAL DAMPENER (K071261)Scient'X2008-04-17
SIERRA (K072729)Seaspine, Inc.2008-04-17
SIERRA SYSTEM (K080526)Seaspine, Inc.2008-04-16
TURBO PRIME IBD SYSTEM (K080058)Spineselect, LLC2008-04-16
ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE (K080736)Apatech , Ltd.2008-04-16
COMPORUS (K062691)Takiron Co., Ltd.2008-04-15
DARCO HEADLESS COMPRESSION SCREW (K080850)Wrightmedicaltechnologyinc2008-04-10
INTREPID SPINAL SYSTEM (K080083)Medtronic Sofamor Danek2008-04-10
INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW (K080434)Smith & Nephew, Inc.2008-04-10
PASS SPINAL SYSTEM (K080099)Medicrea Technologies2008-04-09
K2M COCR ROD (K080792)K2m, Inc.2008-04-08
PROFEMUR LX REVISION 5/8 COATED HIP STEM (K080663)Wrightmedicaltechnologyinc2008-04-08
MODIFICATION TO:PILOT SPINAL SYSTEM (K080502)Life Spine2008-04-08
LDR SPINE ROI-A IMPLANT (K080572)Ldr Spine USA2008-04-07
MODIFIED VERTIFLEX SPINAL SCREW SYSTEM (K073143)Vertiflex, Inc.2008-04-07
WELLGRAFT PE I (K072444)Gwowei Technology Co., Ltd.2008-04-04
EXPEDIUM 4.5MM SPINE SYSTEM (K073364)Depuy Spine, Inc.2008-04-04
WELLGRAFT PE II (K072170)Gwowei Technology Co., Ltd.2008-04-04
EAGLE PLUS MICRO ANTERIOR CERVICAL PLATE SYSTEM (K080191)Depuy Spine, Inc.2008-04-02
ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL HEAD, MODEL 520-38 (K080402)Encore Medical L.P.2008-03-28
SPINOUS PROCESS PLATE SYSTEM (K073278)Nuvasive, Inc.2008-03-28
AVS PL PEEK SPACERS, MODELS 48351 AND 48353 (K080758)Stryker Corp.2008-03-27
DISTAL HUMERAL PLATES WITH ANGULAR STABILITY (K080184)I.T.S. Implantat-Technologie-Systeme GmbH2008-03-26
BIOFLEX (K072321)Biospine Co., Ltd.2008-03-25
AAP CANNULATED SCREW AND DARCO HEADED SCREW (K080101)Aap Implantate AG2008-03-25
CAYMAN BUTTRESS PLATE SYSTEM (K080302)K2m, Inc.2008-03-24
VERTEBRON VBR SYSTEM (K073502)Vertebron, Inc.2008-03-24
BONE FIXATION WIRE (KIRSCHNER WIRE) (K073674)Signal Medical Corp.2008-03-24
AAP BONE PLATES AND SCREW IMPLANTS (K072411)Aap Implantate AG2008-03-20
MODULAR FOOT SYSTEM (K073624)Orthohelix Surgical Designs, Inc.2008-03-20
SAVANNAH LUMBAR PERCUTANEOUS STABILIZATION SYSTEM (K072116)Neurospine Innovations and Solutions2008-03-20
VANGUARD KNEE SYSTEM TITANIUM FEMORAL COMPONENTS (K080204)Biomet, Inc.2008-03-20
PSS SYSTEM (K073240)Spinal USA2008-03-20
PIONEER LOWTOP SPINAL ROD SYSTEM (K080504)Pioneer Surgical Technology2008-03-20
PARALLEL-SIDED EXTENSIVELY COATED FEMORAL STEMS (K073637)Biomet Manufacturing Corp2008-03-20
SYNTHES (USA) MODULAR BLADE PLATE SYSTEM (K080109)Synthes (Usa)2008-03-20
PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM (K080518)Pioneer Surgical Technology2008-03-20
VARIAX DISTAL RADIUS TORX SCREWS (K080667)Howmedica Osteonics Corp.2008-03-19
SBI SR MTP TOE IMPLANT (K073635)Small Bone Innovations, Inc.2008-03-19
HENKE SASS WOLF OF AMERICA ARTHROSCOPE (K080560)Henke Sass Wolf of America, Inc.2008-03-18
SUB-TALAR LOK, MODEL 7-11 MM (K080280)Instratek, Inc.2008-03-14
BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SYSTEM (K080394)Blackstone Medical, Inc.2008-03-13
BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES (K073567)Zimmer GmbH2008-03-13
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