meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
32
Latest Decision
2004-08-31

Clearances · page 110 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K041089 OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM Biomet Manufacturing, Inc. MQV Class II 2004-08-31
K041601 SURFIX KNEE OSTEOTOMY SYSTEM Surfix Technologies HRS Class II 2004-08-27
K040947 DURASUL BIPOLAR Centerpulse Orthopedics, Inc. KWY Class II 2004-08-27
K040928 EXPANDABLE PEEK VBR IMPLANT Interpore Cross Intl. MQP Class II 2004-08-27
K042078 ENDOTINE FOREHEAD TRIPLE DEVICE Coapt Systems, Inc. HWC Class II 2004-08-27
K041421 NAME BONE VOID FILLER Stryker Biotech MQV Class II 2004-08-26
K041616 BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID Orthos (Uk) Limited MQV Class II 2004-08-25
K041613 NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE Novabone Products, LLC MQV Class II 2004-08-25
K040191 BICONTACT HIP STEM AND FEMORAL HEAD Aesculap LPH Class II 2004-08-25
K041873 AEQUALIS REVERSED SHOULDER PROSTHESIS Tornier PHX Class II 2004-08-25
K040734 MODIFICATION TO RESTORATION MODULAR SYSTEM Howmedica Osteonics Corp. LZO Class II 2004-08-25
K042066 KLSA MARTIN HAND DISTRACTOR KLS-Martin L.P. JEC Class II 2004-08-25
K041451 ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50 Ascension Orthopedics, Inc. KYI Class II 2004-08-25
K041456 SNAP-OFF SCREWS Fournitures Hospitalieres Industrie HWC Class II 2004-08-25
K042025 MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek, Inc. KWQ Class II 2004-08-25
K041889 TRI-OSTETIC Berkeley Advanced Biomaterials, Inc. MQV Class II 2004-08-19
K040542 SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW Smith & Nephew, Inc. HWC Class II 2004-08-19
K041493 CEMENTEK Teknimed, S.A. MQV Class II 2004-08-19
K041205 EXPEDIUM ANTERIOR SPINE SYSTEM Depuy Spine, Inc. KWQ Class II 2004-08-17
K041939 BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM LORDOTIC LATERAL SPACERS Blackstone Medical, Inc. MQP Class II 2004-08-17
K041393 FASSIER-DUVAL TELSCOPIC IM SYSTEM Pega Medical, Inc. HSB Class II 2004-08-17
K031714 INION TRINION BIODEGRADABLE MENISCUS SCREW Inion , Ltd. HWC Class II 2004-08-16
K041447 NUVASIVE ANTERIOR CERVICAL PLATE SYSTEM Nuvasive, Inc. KWQ Class II 2004-08-16
K033707 POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX Osteobiologics, Inc. MQV Class II 2004-08-16
K033918 EBI LACTOSORB GRAFT CONTAINMENT SYSTEM Ebi, L.P. HRS Class II 2004-08-16
K041461 KMI DISTAL VOLAR RADIUS PLATE SYSTEM Kinetikos Medical, Inc. HRS Class II 2004-08-16
K041888 CURVED PEEK TETRIS SPINAL IMPLANT Signus Medizintechnik GmbH MQP Class II 2004-08-10
K041197 MODIFICATION TO VERTE-STACK SPINAL SYSTEM Medtronic Sofamor Danek MQP Class II 2004-08-09
K040731 STRYKER SPINE VERTEBRAL SPACER Stryker Spine MQP Class II 2004-08-05
K041289 TALUS OF VILEX (TOV) Vilex, Inc. HWC Class II 2004-08-05
K033580 NEXFLEX TOTAL HIP SYSTEM Nexmed, Inc. LPH Class II 2004-08-05
K041287 VILEX BONE PLATE SYSTEM Vilex, Inc. HWC Class II 2004-08-05
K040082 PORE-SI BONE GRAFT SUBSTITUTE Apatech , Ltd. MQV Class II 2004-08-04
K041168 ALLOMATRIX PUTTY Wrightmedicaltechnologyinc MQV Class II 2004-08-02
K041352 COMPRESS DISTAL FEMORAL REPLACEMENT SYSTEM Biomet, Inc. KRO Class II 2004-07-30
K041355 HUMERAL STAPLE Smith & Nephew, Inc. HTY Class II 2004-07-30
K041157 MODIFICATION TO SMALL BONE FIXATION SYSTEM Hand Innovations, Inc. HTY Class II 2004-07-30
K041469 ANTERIOR COMPACT SYSTEM X-Spine Systems KWQ Class II 2004-07-30
K041128 SUTURE ARROW Linvatec Corp. MAI Class II 2004-07-29
K033313 QUATRO M FEMORAL COMPONENT Whiteside Biomechanics, Inc. LWJ Class II 2004-07-28
K041274 RESORBABLE INTERFERENCE SCREW Arthrotek, Inc. HWC Class II 2004-07-28
K041105 MACROPORE HYDROSORB SPINE SYSTEM Macropore Biosurgery, Inc. KWQ Class II 2004-07-28
K033930 KAPP CUSTOM ULNAR HEAD WRIST IMPLANT Kapp Surgical Instrument, Inc. KXE Class II 2004-07-28
K041233 ARTHROJET XT Hydrocision, Inc. HRX Class II 2004-07-28
K040844 LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM Life Spine, LLC KWQ Class II 2004-07-23
K041842 NORIAN SRS FAST SET PUTTY Synthes (Usa) MQV Class II 2004-07-23
K041167 PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM Pioneer Surgical Technology NKB Class II 2004-07-23
K040483 EQUESTRA FLUID DELIVERY SYSTEM Medtronic Sofamor Danek, Inc. HRX Class II 2004-07-23
K041085 LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY Depuy, Inc. JWH Class II 2004-07-22
K041713 SUPER REVO HERCULINE SUTURE ANCHOR Linvatec Corp. MBI Class II 2004-07-22
K041109 ZIMMER ANATOMIC II HIP PROSTHESIS Zimmer, Inc. LPH Class II 2004-07-20
K041119 EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. KWP Class II 2004-07-19
K041794 C-TEK C-THRU ANTERIOR CERVICAL PLATE SYSTEM Interpore Cross Intl. KWQ Class II 2004-07-19
K040980 ALLOMATRIX C PUTTY, ALLOMATRIX CUSTOM PUTTY, ALLOMATRIX DR PUTTY, IGNITE SCAFFOLD, MODELS 860C, 86XC, 86DR, 860D, 860T Wrightmedicaltechnologyinc MQV Class II 2004-07-14
K041586 PROFEMUR S HIP STEM Wrightmedicaltechnologyinc JDL Class III 2004-07-09
K041454 KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A Kyphon, Inc. HRX Class II 2004-07-09
K040281 LPS METAPHYSEAL SLEEVE (LIMB PRESERVATION SYSTEM) DePuy Orthopaedics, Inc. JWH Class II 2004-07-09
K033679 COPSIOS BONE VOID FILLER (BVF) Centerpulse Spine-Tech, Inc. MQV Class II 2004-07-07
K041584 KYPHX HV-R BONE CEMENT, MODEL C01A Kyphon, Inc. NDN Class II 2004-07-07
K033926 HOURGLASS VERTEBRAL BODY SPACER Medtronic Sofamor Danek MQP Class II 2004-07-07
K040935 EBI XFIX DFS SYSTEM Ebi, L.P. KTT Class II 2004-07-06
K032905 3DKNEE POROUS COATED FEMORAL COMPONENT Encore Orthopedics, Inc. MBH Class II 2004-07-06
K033959 LPS Depuy, Inc. JWH Class II 2004-07-01
K033826 ORTHOPEDIC ALLIANCE SPINE SYSTEM Orthopedic Alliance, LLC MNI Class II 2004-07-01
K041656 MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT DePuy Orthopaedics, Inc. LOD Class II 2004-07-01
K041449 SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION SEAT Interpore Cross Intl. KWP Class II 2004-07-01
K041001 OMEGA 2 SYSTEM Howmedica Osteonics Corp. KTT Class II 2004-07-01
K033951 RADIX CERVICAL PLATE Pisharodi Surgicals, Inc. KWQ Class II 2004-07-01
K041106 REVISION KNEE SYSTEM Smith & Nephew, Inc. JWH Class II 2004-07-01
K041466 TITANIUM FEMORAL KNEE COMPONENTS (MAXIM AND AGC) Biomet Manufacturing Corp JWH Class II 2004-07-01
K040907 ARTHREX SMALL FRAGMENT PLATES AND SCREWS Arthrex, Inc. HRS Class II 2004-07-01
K041460 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. KWQ Class II 2004-07-01
K040938 RADIAL NAIL SYSTEM Wrightmedicaltechnologyinc HRS Class II 2004-07-01
K041081 FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES Hand Innovations, Inc. KTT Class II 2004-07-01
K041556 MODIFICATION TO VERTE-STACK SPINAL SYSTEM Medtronic Sofamor Danek MQP Class II 2004-07-01
K040096 SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM Spinal Concepts, Inc. KWP Class II 2004-07-01
K041030 MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek MNI Class II 2004-06-30
K033355 LACTOSCREW SCREW ANCHOR Biomet Orthopedics, Inc. HWC Class II 2004-06-30
K041440 OPUS MAGNUM ANCHOR WITH INSERTER Opus Medical, Inc. MBI Class II 2004-06-25
K040908 EBI DISTAL RADIUS PLATING SYSTEM Ebi, L.P. HRS Class II 2004-06-25
K041425 CONSERVE PLUS REVISION SHELL AND CONSERVE PLUS THICK SHELL Wrightmedicaltechnologyinc KWA Class III 2004-06-25
K041452 MODIFICATION TO VERTE-STACK SPINAL SYSTEM Medtronic Sofamor Danek MQP Class II 2004-06-24
K033303 WAFER SYSTEM Spine Wave, Inc. HRS Class II 2004-06-24
K031939 BIO-EUROLIG INTERFERENCE SCREW Fournitures Hospitalieres Industrie HWC Class II 2004-06-24
K040850 TSY SHOULDER PLATE IMPLANT Orthopedic Sciences, Inc. HRS Class II 2004-06-24
K040777 LCP RADIAL HEAD PLATING SYSTEM Synthes (Usa) HRS Class II 2004-06-18
K040612 SKY BONE EXPANDER SYSTEM (SKY SYSTEM) Disc-O-Tech Medical Technologies, Ltd. HRX Class II 2004-06-17
K040860 INTEGRA BONE FIXATION SYSTEM Integra LifeSciences Corporation HRS Class II 2004-06-17
K041339 AEQUALIS SHOULDER SYSTEM Tornier KWS Class II 2004-06-17
K040755 EXACTECH RESORBABLE ROOM TEMPERATURE BONE PASTE Exactech, Inc. MQV Class II 2004-06-17
K040749 MODULAR REPLACEMENT SYSTEM CEMENTED STEMS Howmedica Osteonics Corp. KRO Class II 2004-06-17
K040721 ASSURE ANTERIOR CERVICAL PLATE SYSTEM Globus Medical, Inc. KWQ Class II 2004-06-17
K040747 ALADYN RIGID SPINE PLATE Scient'X MNH Class II 2004-06-17
K040701 SYNTHES (USA) HYDROXYAPATITE (HA) COATED SCHANZ SCREWS Synthes (Usa) HWC Class II 2004-06-15
K041305 STRYKER BIOZIP SUTURE ANCHOR SYSTEM Stryker Endoscopy MAI Class II 2004-06-14
K041310 STRYKER WEDGE SUTURE ANCHOR SYSTEM Stryker Endoscopy MBI Class II 2004-06-14
K040680 CONTOUR HA COATED RECONSTRUCTION RING Smith & Nephew, Inc. MEH Class II 2004-06-14
K041307 MODIFICATION TO STRYKER XCEL ANCHOR SYSTEM Stryker Endoscopy MAI Class II 2004-06-14
K041288 MODIFICATION TO SMARTPIN Linvatec Biomaterials, Inc. HTY Class II 2004-06-10
K033552 JAX-TCP Smith & Nephew, Inc. MQV Class II 2004-06-10

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