meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
37
Latest Decision
2004-03-23

Clearances · page 112 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K040064 NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR Newmedical Technology, Inc. KTT Class II 2004-03-23
K040284 SUSTAIN RADIOLUCENT SPACER Globus Medical, Inc. MQP Class II 2004-03-23
K033109 ELLYS AND AURYS VERTEBRAL BODY REPLACEMENTS Scient'X MQP Class II 2004-03-23
K040258 SYNTHES MEDIUM EXTERNAL FIXATION SYSTEM-MR SAFE Synthes (Usa) KTT Class II 2004-03-23
K040250 BONE-LOK HP WASHER Triage Medical, Inc. HTN Class II 2004-03-23
K040422 MODIFICATION TO VERTE-STACK Medtronic Sofamor Danek MQP Class II 2004-03-19
K040346 MODIFICATION TO ORIA TOP CLIP SYSTEM Ortho Tec, LLC MNI Class II 2004-03-12
K040112 TRIMED BEARING PLATE; TRIMED VOLAR BEARING PLATE Tri-Med, Inc. HRS Class II 2004-03-12
K033893 SPECTRUM MODULAR SYSTEM DePuy Orthopaedics, Inc. LPH Class II 2004-03-12
K040022 STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEM Stryker Leibinger HRS Class II 2004-03-12
K033944 STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD Stelkast Company LZO Class II 2004-03-12
K033351 GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE Global Orthopaedic Technology, USA, Inc. HRY Class II 2004-03-11
K034028 ATH FEMORAL STEM Wrightmedicaltechnologyinc JDI Class II 2004-03-11
K040134 THERILINK BONE VOID FILLER Therics, Inc. MQV Class II 2004-03-09
K033258 BONESAVE BONE VOID FILLER Howmedica Osteonics MQV Class II 2004-03-09
K032560 ARROWHEAD SPINAL SYSTEM Medtronic Sofamor Danek NKB Class II 2004-03-09
K040405 CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY Berkeley Advanced Biomaterials, Inc. MQV Class II 2004-03-05
K033810 NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEM Centerpulse Orthopedics, Inc. HRY Class II 2004-03-05
K031511 DYNESYS SPINAL SYSTEM Centerpulse Spine-Tech, Inc. NQP Class II 2004-03-05
K020895 ALLOMATRIX MODEL# 86 Wrightmedicaltechnologyinc MQV Class II 2004-03-05
K033947 SHIRAZ POSTERIOR SYSTEM Spine Next America MNI Class II 2004-03-04
K031100 SYNTHES VENTROFIX MIS SYSTEM Synthes (Usa) KWQ Class II 2004-03-04
K033965 SHIRAZ-ANTERIOR SYSTEM Spine Next America KWQ Class II 2004-03-04
K033980 BLACKSTONE ASCENT POCT SYSTEM HOOKS (SYSTEM MODIFICATION) Blackstone Medical, Inc. KWP Class II 2004-03-03
K033816 SYNTHES (USA) MODIFICATION TO STERNAL RECONSTRUCTION SYSTEM Synthes (Usa) JDQ Class II 2004-03-02
K031961 INION OTPS BIODEGRADABLE MESH PLATING SYSTEM Inion , Ltd. HRS Class II 2004-03-01
K033150 ART POSTERIOR SPINAL SYSTEM Advanced Medical Technologies AG MNI Class II 2004-03-01
K040356 KOMPRESSOR SCREW SYSTEM Kinetikos Medical, Inc. HWC Class II 2004-03-01
K033975 SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS Synthes (Usa) HWC Class II 2004-03-01
K023684 CANNULATED METALLIC HEMI TOE IMPLANT, MODELS MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365 Vilex, Inc. KWD Class II 2004-03-01
K033792 BILOK ST SCREW Biocomposites, Ltd. HWC Class II 2004-03-01
K033995 3.5 MM LCP DISTAL HUMERUS SYSTEM Synthes (Usa) KTT Class II 2004-03-01
K020078 EXACTECH RESORBABLE BONE PASTE Exactech, Inc. MQV Class II 2004-02-27
K033352 VERTEBRON PSS PEDICLE SCREW SYSTEM Vertebron, Inc. MNI Class II 2004-02-25
K033717 TRANSET FRACTURE FIXATION SYSTEM Bonutti Research, Inc. HTY Class II 2004-02-25
K033749 TITANIUM CANNULATED INTERFERENCE SCREW Advanced Biomaterials HWC Class II 2004-02-23
K040166 DEPUY SIGMA XLK TIBIAL INSERTS DePuy Orthopaedics, Inc. JWH Class II 2004-02-23
K033806 ACE PROXIMAL HUMERAL NAIL SYSTEM Depuy Ace HSB Class II 2004-02-20
K032394 STRYKER SPINE OASYS SYSTEM Howmedica Osteonics Corp. MNI Class II 2004-02-20
K033878 ACE ANTEGRADE RETROGRADE HUMERAL NAIL SYSTEM Depuy Ace HSB Class II 2004-02-20
K040212 TRIGEN INTERTAN Smith & Nephew, Inc. JDS Class II 2004-02-20
K040199 OSSE-LIGN, 1.5MM COCR AND SS CABLE SYSTEM AND COMPONENTS Osseus, LLC JDQ Class II 2004-02-20
K033805 SYNTHES (USA) 3.5 / 4.5 MM LCP METAPHYSEAL PLATES Synthes (Usa) LXT Class II 2004-02-20
K033968 HANSSON PIN SYSTEM Howmedica Osteonics Corp. HTY Class II 2004-02-20
K032064 THEKEN CPOD/LPOD VERTEBRAL BODY REPLACEMENT SYSTEM Theken Surgical,Llc MQP Class II 2004-02-20
K033517 SPINAL CONCEPTS INC. CADENCE AND TRAXIS Spinal Concepts, Inc. MQP Class II 2004-02-18
K040167 VERTE-STACK SPINAL SYSTEM Medtronic Sofamor Danek MQP Class II 2004-02-18
K031859 CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT Arthrosurface, Inc. KWD Class II 2004-02-18
K033769 EIUS UNICOMPARTMENTAL KNEE SYSTEM Howmedica Osteonics Corp. HSX Class II 2004-02-13
K033883 OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED FEMORAL COMPONENTS, HI-FLEX POSTERIOR-STABI Exactech, Inc. JWH Class II 2004-02-13
K033838 TITANIUM TOGGLE BUTTON(S) Biomet Manufacturing, Inc. MBI Class II 2004-02-13
K032371 TITANIUM MESH SYSTEM Encore Medical L.P. MQP Class II 2004-02-12
K040072 MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek, Inc. MNH Class II 2004-02-12
K032815 PRECISION SURGERY LIMITED VARIABLE AND FIXED CERVICAL PLATE SYSTEM Precision Surgery Limited KWQ Class II 2004-02-12
K040034 BLACKSTONE ASCENT POCT SYSTEM LATERAL OFFSET ADAPTER Blackstone Medical, Inc. MNI Class II 2004-02-11
K033573 LINVATEC 10K IRRIGATION SYSTEM Linvatec Corp. HRX Class II 2004-02-11
K033756 VOLAR RADIUS PLATE WITH ANGULAR STABILITY I.T.S. Implantat-Technologie-Systeme GmbH HRS Class II 2004-02-06
K033563 SMARTSET GHV GENTAMICIN BONE CEMENT DePuy Orthopaedics, Inc. LOD Class II 2004-02-05
K033618 SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM Synthes (Usa) HSB Class II 2004-02-05
K033844 SYNTHES ANTERIOR CERVICAL COMPRESSION SYSTEM Synthes (Usa) KWQ Class II 2004-02-05
K033382 SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT DePuy Orthopaedics, Inc. LOD Class II 2004-02-05
K033272 DEPUY SIGMA TIBIAL INSERTS DePuy Orthopaedics, Inc. JWH Class II 2004-02-05
K030877 TRIMED RADIAL BULLET Tri-Med, Inc. HRS Class II 2004-02-05
K033506 COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE Biomet, Inc. KWS Class II 2004-02-02
K033456 EVOLVE RADIAL PLATE Wrightmedicaltechnologyinc HRS Class II 2004-01-28
K034037 SKY BONE EXPANDER SYSTEM Disc-O-Tech Medical Technologies, Ltd. HRX Class II 2004-01-28
K033508 PLUS PIVOT LINK UNIVERSAL SYSTEM Spine Vision, Inc. MNI Class II 2004-01-27
K033772 SHIRAZ-JAVA SPINAL FIXATION SYSTEM Spine Next America MNI Class II 2004-01-27
K033193 SONOSENS Friendly Sensors AG NKI Class II 2004-01-23
K022908 POSTERIOR CABLE SCREW Pioneer Surgical Technology MNI Class II 2004-01-22
K031841 SPACER G TEMPORARY HIP PROSTHESIS Exactech, Inc. KWL Class II 2004-01-22
K032604 GII SPINAL FIXATION SYSTEM Co-Ligne AG MNH Class II 2004-01-20
K033476 MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM Howmedica Osteonics Corp. KTT Class II 2004-01-20
K032641 MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM Portland Orthopaedics Pty. , Ltd. MEH Class II 2004-01-20
K033363 ZIMMER UNICOMPARTMENTAL KNEE SYSTEM Zimmer, Inc. HSX Class II 2004-01-16
K033927 ARTHOSCOPY PUMP A115 W.O.M. World of Medicine AG HRX Class II 2004-01-15
K032891 TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT Trans1, Inc. HRX Class II 2004-01-15
K033890 ADVANCE DOUBLE HIGH INSERT Wrightmedicaltechnologyinc JWH Class II 2004-01-15
K033342 SCORPIO KNEE SYSTEM - TIBIAL INSERTS Howmedica Osteonics Corp. JWH Class II 2004-01-15
K032108 SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED) Aesculap, Inc. MBH Class II 2004-01-15
K033639 ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM Acumed, LLC HWC Class II 2004-01-15
K024185 BIODHOC Future Medical Systems, SA HTY Class II 2004-01-15
K033406 SMALL BONE FIXATION SYSTEM Hand Innovations, Inc. HTY Class II 2004-01-15
K034002 GAMMA3 NAIL SYSTEM Howmedica Osteonics Corp. HSB Class II 2004-01-15
K033556 SYNTHES (USA) LCP DYNAMIC HELICAL HIP SYSTEM Synthes (Usa) KTT Class II 2004-01-13
K033312 EBI TOP LOADING MAS SPINAL FIXATION SYSTEM Ebi, L.P. NKB Class II 2004-01-13
K032966 THE ANSWER SCREW SUPPLEMENTATION SYSTEM Simplicity Orthopedic Solutions, LLC HWC Class II 2004-01-13
K033289 MODIFICATION TO JET-X HA COATED HALF PINS Smith & Nephew, Inc. JDW Class II 2004-01-13
K033286 ODI TALON LONG PROXIMAL FEMORAL NAIL SYSTEM Orthopedic Designs, Inc. (Odi) HSB Class II 2004-01-12
K032126 PROMOS SHOULDER Plus Orthopedics HSD Class II 2004-01-08
K031962 NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS Implex Corp. JWH Class II 2004-01-08
K033338 PINNACLE REVISION SYSTEM DePuy Orthopaedics, Inc. LPH Class II 2004-01-08
K033837 STRYKER SPINE VERTEBRAL BODY SUPPORT SYSTEM Howmedica Osteonics Corp. MQP Class II 2004-01-08
K033804 BIOANCHOR WITH DISPOSABLE DRIVER Linvatec Corp. HWC Class II 2003-12-31
K033242 KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS) Imaging Therapeutics, Inc. HSH Class II 2003-12-31
K033046 SUBTALAR PEG IMPLANT Nexa Orthopedics, Inc. MJW Class II 2003-12-23
K032288 VITOSS SCAFFOLD FOAM BONE GRAFT MATERIAL Orthovita, Inc. MQV Class II 2003-12-19
K032950 GEM INSET PATELLAR COMPONENT Kinamed, Inc. JWH Class II 2003-12-19
K032219 REVOLUTION SPINAL FIXATION SYSTEM Spinal Innovations, Inc. MNI Class II 2003-12-19
K033280 DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEM Biomet, Inc. JDC Class II 2003-12-19

17,115 clearances in the Orthopedic panel. Data: openFDA.