meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
33
Latest Decision
2006-10-24

Clearances · page 100 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K062148 DEPUY PINNACLE ALTRX ACETABULAR CUP LINER DePuy Orthopaedics, Inc. LPH Class II 2006-10-24
K062853 MODIFICATION TO STRYKER SPINE OASYS SYSTEM Stryker Spine MNI Class II 2006-10-24
K062903 SBI CARPAL FUSION PLATE Small Bone Innovations, Inc. HRS Class II 2006-10-20
K062352 FRS SCREW DePuy Orthopaedics, Inc. HWC Class II 2006-10-19
K062496 OSTEOPORE TCP Spinecraft, Inc. MQV Class II 2006-10-19
K061863 ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY Arthrex, Inc. HWC Class II 2006-10-19
K062831 MODIFICATION TO LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM Life Spine KWQ Class II 2006-10-19
K062564 SYNTHES LCP DISTAL FEMUR PLATES Synthes (Usa) HRS Class II 2006-10-19
K061681 REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT Biomet Manufacturing Corp HRY Class II 2006-10-19
K062494 EBI OPTILOCK UPPER EXTREMITY PLATING SYSTEM Ebi, L.P. HRS Class II 2006-10-19
K062810 SOLITAIRE ANTERIOR SPINAL SYSTEM Ebi, L.P. MQP Class II 2006-10-17
K062768 NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED FLEX FIXED BEARING AND TIVANIUM TI-6AL-4V ALLOY FEMORAL Zimmer, Inc. JWH Class II 2006-10-13
K062301 DEPUY LPS PROXIMAL TIBIAL COMPONENT DePuy Orthopaedics, Inc. KRO Class II 2006-10-13
K062495 HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SYSTEM Depuy Spine, Inc. MQV Class II 2006-10-13
K062698 TRIO + SPINAL SYSTEM Stryker Spine MNI Class II 2006-10-11
K062685 EBI ARAY SPINAL SYSTEM Ebi, L.P. NKB Class II 2006-10-06
K062136 PASS 2 SPINAL SYSTEM Medicrea MNI Class II 2006-10-06
K062686 UNIVERSAL SPINAL ANTERIOR LOCKING PLATE SYSTEM Advanced Spine Technology, Inc. KWQ Class II 2006-10-05
K062617 MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEM Inion , Ltd. HWC Class II 2006-10-04
K062040 SBI TRIHEDRON MTP HEMI GT Small Bone Innovations, Inc. KWD Class II 2006-10-03
K062113 SOLAR REUNION FRACTURE STEM Howmedica Osteonics Corp. KWS Class II 2006-10-03
K062654 DEPUY SIGMA CRUCIATE RETAINING POROCOAT FEMORAL COMPONENTS DePuy Orthopaedics, Inc. MBH Class II 2006-09-29
K062693 GLADIATOR BIPOLAR SYSTEM Wrightmedicaltechnologyinc KWY Class II 2006-09-29
K062747 ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MM Arthrex, Inc. HRS Class II 2006-09-29
K062679 ARTHREX CORKSCREW FT III SUTURE ANCHOR WITH THREE #2 SUTURES Arthrex, Inc. HWC Class II 2006-09-27
K062505 NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES Abbott Spine, Inc. MNI Class II 2006-09-26
K061524 ISS INTEGRATED SPINE SYSTEM Ortho Development Corp. MNH Class II 2006-09-26
K062133 MODIFICATION TO VERTE-STACK SPINAL SYSTEM Medtronic Spinal and Biologics Div MQP Class II 2006-09-26
K061340 23 MM SINGLE-PEG PATELLA COMPONENT Biomet Manufacturing, Inc. JWH Class II 2006-09-25
K061776 ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE Arthrotek, Inc. JDR Class II 2006-09-25
K061949 DOUBLEPLAY SUTURE ANCHOR Biocomposites, Ltd. HWC Class II 2006-09-25
K062606 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek MNI Class II 2006-09-25
K061155 VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM Zimmer Trabecular MQP Class II 2006-09-22
K060917 KENSEY NASH BONE VOID FILLER Kensey Nash Corporation MQV Class II 2006-09-22
K061311 ALLOGRAN-R Biocomposites, Ltd. MQV Class II 2006-09-22
K062452 KIT MENDEC SPINE AND DELIVERY SYSTEM Tecres S.P.A. NDN Class II 2006-09-21
K061910 SYNTHES (USA) [SYNTHES] ANGULAR STABLE LOCKING SYSTEM (ASLS) Synthes (Usa) HSB Class II 2006-09-21
K061813 MANTIS SPINAL SYSTEM Stryker Spine MNH Class II 2006-09-19
K061763 ARC SURGICAL BIOTRAK SCREW Arc Surgical, LLC HWC Class II 2006-09-19
K062216 PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM Smith & Nephew, Inc. HRS Class II 2006-09-15
K062424 CONFIDENCE EX HIGH VISCOSITY BONE CEMENT Disc-O-Tech Medical Technologies, Ltd. NDN Class II 2006-09-14
K061577 OVALTWIST PEDICLE SCREW SYSTEM Signus Medizintechnik GmbH MNH Class II 2006-09-14
K060762 AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM Aesculap, Inc. MQP Class II 2006-09-14
K062427 VERTE-STACK SPINAL SYSTEM Medtronic Sofamor Danek MQP Class II 2006-09-12
K062408 SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD Smith & Nephew, Inc. KWL Class II 2006-09-12
K061668 OPTECURE +CCC Exactech, Inc. MBP Class II 2006-09-12
K061973 SYNTHES 3.5MM SPRING PLATE Synthes (Usa) HRS Class II 2006-09-11
K062196 SFX SNAP-FIT CROSS CONNECTOR Depuy Spine, Inc. MNH Class II 2006-09-11
K061648 DEPUY GRADUATED COMPARTMENTAL KNEE (GCK) DePuy Orthopaedics, Inc. NPJ Class II 2006-09-11
K061591 MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek, Inc. KWP Class II 2006-09-08
K062348 TIMESH SELF DRILLING SCREW Medtronic Neurosurgery HWC Class II 2006-09-08
K061940 SYNTHES LCP ANKLE ARTHRODESIS PLATES Synthes (Usa) HRS Class II 2006-09-08
K051165 KLS MARTIN STERNAL TALON KLS-Martin L.P. HRS Class II 2006-09-07
K060180 BIOSET XC Regeneration Technologies, Inc. MBP Class II 2006-09-06
K062407 GATEWAY THORACOLUMBAR PLATE SYSTEM Globus Medical, Inc. KWQ Class II 2006-09-06
K053418 SYNTHES OC FUSION SYSTEM Synthes Spine Co.Lp KWP Class II 2006-09-06
K061759 REPROCESSED EXTERNAL FIXATION DEVICE Ascent Healthcare Solutions KTT Class II 2006-09-05
K061364 PILOT POSTERIOR LUMBAR PLATING SYSTEM Life Spine MNH Class II 2006-09-05
K061564 PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD Portland Orthopaedics Pty. , Ltd. LZO Class II 2006-09-01
K061134 EBERLE SHAVER SYSTEM C2 AND SHAVER BLADES Efs Eberle Feinwerktechnische Systeme HRX Class II 2006-09-01
K062317 MODIFICATION TO NUVASIVE SPHERX II SYSTEM Nuvasive, Inc. MNH Class II 2006-09-01
K052687 CONFORMIS, INC. TOTAL KNEE REPAIR SYSTEM Conformis, Inc. JWH Class II 2006-08-31
K061531 SPACE CPSXL BONE CEMENT Dfine, Inc. NDN Class II 2006-08-30
K061353 TRINICA ANTERIOR LUMBAR PLATE SYSTEM Zimmer Spine, Inc. KWQ Class II 2006-08-30
K061221 DUPUY S-ROM STD HIP STEM PROSTHESIS DePuy Orthopaedics, Inc. KWA Class III 2006-08-28
K061862 AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM Axiom Orthopaedics, Inc. HSD Class II 2006-08-28
K061917 DISTAL RADIUS LOCKING PLATING SYSTEM Newclip Technics HRS Class II 2006-08-28
K060072 MONOBLOCK PRESS-FIT HIP STEM Omni Life Science, Inc. LPH Class II 2006-08-24
K061246 ENDOSCOPIC SPINE SYSTEM Arthro Kinetics, Inc. HRX Class II 2006-08-23
K062170 BIOKNOTLESS AND LUPINE PLUS ANCHORS Depuy Mitek, A Johnson & Johnson Company JDR Class II 2006-08-22
K061434 TRIDENT LARGE DIAMETER HIP SYSTEM Howmedica Osteonics Corp. LPH Class II 2006-08-22
K061600 ARX SPINAL SYSTEM Life Spine MNI Class II 2006-08-22
K061433 VANGUARD ANATOMIC PATELLA GROOVE (APG) / VANGUARD V GROOVE Biomet Manufacturing, Inc. MBH Class II 2006-08-21
K061798 BIOPRO MEMORY STAPLE Biopro, Inc. JDR Class II 2006-08-21
K061401 INTERPLATE VBR SYSTEM Rsb Spine, LLC MQP Class II 2006-08-18
K062116 DELTA CTA REVERSE SHOULDER SYSTEM HUMERAL HEADS DePuy Orthopaedics, Inc. PHX Class II 2006-08-18
K062310 REFLEX HYBRID ACP SYSTEM Stryker Spine KWQ Class II 2006-08-18
K061891 SYNEX II Synthes Spine Co.Lp MQP Class II 2006-08-18
K061699 EXCIA Aesculap, Inc. LWJ Class II 2006-08-18
K061223 ADVANCE TOTAL KNEE SYSTEM Wrightmedicaltechnologyinc MBH Class II 2006-08-18
K061808 DARCO LOCKING BONE PLATE SYSTEM Darco International, Inc. HRS Class II 2006-08-17
K062110 VERTEBRON SCP CERVICAL PLATE SYSTEM Vertebron, Inc. KWQ Class II 2006-08-16
K062132 AVS PL PEEK SPACER SYSTEM Stryker Spine MQP Class II 2006-08-16
K062066 OMEGA 3 SYSTEM Howmedica Osteonics Corp. KTT Class II 2006-08-15
K062004 MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT Quantum Orthopedics, Inc. MQP Class II 2006-08-15
K061752 SPINAL USA VBR SYSTEM Spinal USA MQP Class II 2006-08-15
K053505 REGENEREX ULTRA POROUS CONSTRUCT-FEMORAL AND TIBIAL KNEE AUGMENTS Biomet Manufacturing, Inc. MBH Class II 2006-08-14
K062073 VERTE-STACK SPINAL SYSTEM Medtronic Sofamor Danek MQP Class II 2006-08-14
K061978 EBI, L.P.'S LINE EXTENSION TO THE ARRAY SPINAL SYSTEM Ebi, L.P. MNI Class II 2006-08-11
K061451 ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 Ascension Orthopedics, Inc. KYI Class II 2006-08-11
K061579 MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek KWP Class II 2006-08-11
K061521 TRIATHLON METAL BACKED PATELLA Howmedica Osteonics Corp. MBH Class II 2006-08-11
K061017 EASYSPINE SYSTEM Ldr Spine USA MNI Class II 2006-08-10
K061783 KNEE FUSION NAIL Smith & Nephew, Inc. JDS Class II 2006-08-10
K061789 LATERAL PLATE SYSTEM Nuvasive, Inc. KWQ Class II 2006-08-10
K061938 VERTE-STACK SPINAL SYSTEM Medtronic Sofamor Danek, Inc. MQP Class II 2006-08-09
K061801 2.8 & 3.5MM LACTOSCREW SUTURE ANCHORS Arthrotek, Inc. JDR Class II 2006-08-07
K061779 COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE Smith & Nephew, Inc. HSX Class II 2006-08-04
K061955 RAYHACK LOW PROFILE LOCKING PLATE AND INSTRUMENTS Creative Medical Designs, Inc. HRS Class II 2006-08-04
K061753 SYNTHES (USA) CLAVICLE HOOK PLATES Synthes (Usa) HRS Class II 2006-08-04

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