meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
37
Latest Decision
2004-06-10

Clearances · page 111 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K041282 MODIFICATION TO TSRH SPINAL SYSTEM Medtronic Sofamor Danek, Inc. KWP Class II 2004-06-10
K041261 FEMORAL HOOK Arthrotek, Inc. MBI Class II 2004-06-07
K040611 MODULAR RADIAL HEAD REPLACEMENT DEVICE Biomet, Inc. KWI Class II 2004-06-04
K040610 VERSA-DIAL HUMERAL HEAD Biomet Manufacturing, Inc. KWS Class II 2004-06-04
K040613 EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS Exactech, Inc. MEH Class II 2004-06-04
K033512 PROCYON SPINAL SYSTEM Nas Medical Technologies, Inc. MNH Class II 2004-06-03
K033489 AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN Biomet, Inc. MBH Class II 2004-06-02
K041203 SUMMIT OCT SPINAL SYSTEM Depuy Spine, Inc. MNI Class II 2004-06-02
K040655 SWIFT ANTERIOR CERVICAL PLATE SYSTEM Depuy Spine, Inc. KWQ Class II 2004-06-02
K040919 NUCLEOTOME PROBE SET, MODEL 21200 Clarus Medical, LLC HRX Class II 2004-06-01
K033971 SCORPIO TOTAL KNEE SYSTEM WITH PERI-APATITE COATING Howmedica Osteonics Corp. MBH Class II 2004-05-28
K040544 DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062 Depuy, Inc. LPH Class II 2004-05-28
K041118 MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek MNI Class II 2004-05-28
K041117 PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS 212132, 212732 Depuy Mitek JDR Class II 2004-05-28
K041114 PROFEMUR TAPERED HIP STEM Wrightmedicaltechnologyinc JDL Class III 2004-05-28
K040265 LITTLE GRAFTER SCREW Biocomposites, Ltd. HWC Class II 2004-05-28
K041116 SUPER QUICKANCHOR PLUS Depuy Mitek JDR Class II 2004-05-28
K041217 MODIFICATION TO BONE GRAFT WASHER Medtronic Sofamor Danek, Inc. KWQ Class II 2004-05-28
K040964 SCORPIO TOTAL KNEE SYSTEM - POSTERIOR STABILIZED TIBIAL INSERTS Howmedica Osteonics Corp. JWH Class II 2004-05-28
K032522 TECRES SPACER-K TEMPORARY KNEE PROSTHESIS Exactech, Inc. JWH Class II 2004-05-28
K041115 GII QUICKANCHOR PLUS Depuy Mitek, A Johnson & Johnson Company JDR Class II 2004-05-28
K033663 SPINAL CONCEPTS INC. CODA Spinal Concepts, Inc. MQP Class II 2004-05-27
K041160 AVON EXTRA-SMALL PATELLO-FEMORAL REPLACEMENT Howmedica Osteonics Corp. KRR Class II 2004-05-27
K040929 TRIGEN ADOLESCENT TAN Smith & Nephew, Inc. HSB Class II 2004-05-25
K040500 ARTHROTEK LACTONAIL Arthrotek, Inc. HTY Class II 2004-05-25
K040412 TRIDENT T ACETABULAR SHELLS Stryker Orthopaedics LPH Class II 2004-05-25
K040656 MODIFICATION TO SMITH & NEPHEW INTRAMEDULLARY HIP SCREW Smith & Nephew, Inc. HWC Class II 2004-05-25
K031673 REFOBACIN -PALACOS G Heraeus Kulzer GmbH & Co. KG LOD Class II 2004-05-25
K032945 SIMPLEX X Stryker Corp. LOD Class II 2004-05-25
K041046 MAXIM ACCEL (VANGUARD) PS+ BEARINGS Biomet, Inc. JWH Class II 2004-05-21
K040475 MICROMAX SUTURE ANCHOR Biomet, Inc. HWC Class II 2004-05-21
K040442 PROTEX STABILIZATION SYSTEM Globus Medical, Inc. MNH Class II 2004-05-20
K040389 COONRAD/MORREY ELBOW CEMENT RESTRICTOR Zimmer, Inc. JDC Class II 2004-05-17
K040017 ABC CAUDAL AND CRANIAL EXTENSION PLATE (E-PLATE) Aesculap, Inc. KWQ Class II 2004-05-14
K040962 MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek KWQ Class II 2004-05-14
K030941 AEQUALIS REVERSED SHOULDER PROSTHESIS Tornier PHX Class II 2004-05-14
K040598 KLS MARTIN HAND PLATING SYSTEM KLS-Martin L.P. HRS Class II 2004-05-13
K041064 BIOKNOTLESS RC ANCHOR Depuy Mitek JDR Class II 2004-05-13
K040381 HATRIC, 6&7MM, 9&10MM, 11&12MM, 14&15MM, MODELS AR-13000B-07, -10, -12, -15 Arthrex, Inc. MQV Class II 2004-05-12
K040939 SKY BONE EXPANDER SYSTEM (SKY SYSTEM) Disc-O-Tech Medical Technologies, Ltd. HRX Class II 2004-05-12
K040383 TRIFLANGE II ACETABULAR CUP SYSTEM DePuy Orthopaedics, Inc. LPH Class II 2004-05-12
K041135 VAPR 3 ELECTROSURGICAL SYSTEM AND VAPR LD AND LP SUCTION ELECTRODES Depuy Mitek, A Johnson & Johnson Company HRX Class II 2004-05-10
K033596 CEMEX GENTA BONE CEMENT; CEMEX GENTA SYSTEM BONE CEMENT Exactech, Inc. LOD Class II 2004-05-10
K040740 ENDOTINE TRANSBLEPH DEVICE Coapt Systems, Inc. HWC Class II 2004-05-10
K040454 BIOFILL BONE VOID FILLER Scient'X MQV Class II 2004-05-07
K040588 SYNTHES (USA) 2.4 MM LCP WRIST PLATE Synthes (Usa) HRS Class II 2004-05-07
K041065 PANALOK RC LOOP ANCHOR Depuy Mitek JDR Class II 2004-05-07
K040600 GENEX BONE GRAFT SUBSTITUTE Biocomposites, Ltd. MQV Class II 2004-05-07
K033722 APAPORE BONE GRAFT SUBSTITUTE Apatech , Ltd. MQV Class II 2004-05-07
K032894 OSTEO ACL SCREW MODEL;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T, Linvatec Biomaterials, Inc. HWC Class II 2004-05-07
K033273 DEPUY PINNACLE ACETABULAR CUP SYSTEM, ESL MARATHON POLYETHYLENE LINERS, AND DEPUY ULTIMA UNIPOLAR FEMORAL HEADS DePuy Orthopaedics, Inc. LPH Class II 2004-05-06
K040225 OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM Osteoimplant Technology, Inc. KWZ Class II 2004-05-06
K040397 MODIFICATION TO CYCLONE ANTERIOR CERVICAL PLATE SYSTEM Encore Medical L.P. KWQ Class II 2004-05-06
K040268 DEPUY PRESERVATION UNICONDYLAR TIBIA DePuy Orthopaedics, Inc. HRY Class II 2004-05-05
K040267 TRIATHLON CRUCIATE RETAINING (CR) TOTAL KNEE Howmedica Osteonics Corp. JWH Class II 2004-05-05
K040536 MODIFICATION TO VERTE-STACK SPINAL SYSTEM Medtronic Sofamor Danek MQP Class II 2004-05-05
K040669 CERAFORM BONE VOID FILLER Teknimed, S.A. MQV Class II 2004-05-03
K040514 EOVIA CALCIUM PHOSPHATE CERAMIC Ortho Tec, LLC MQV Class II 2004-05-03
K031687 VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES Vanguard Medical Concepts, Inc. KTT Class II 2004-04-30
K040827 PANALOK LOOP ANCHOR Depuy Mitek, A Johnson & Johnson Company MAI Class II 2004-04-30
K022688 VERSABOND AB BONE CEMENT Smith & Nephew, Inc. LOD Class II 2004-04-29
K040803 MS-30 FEMORAL STEM STANDARD AND LATERAL Zimmer, Inc. LZO Class II 2004-04-29
K040833 MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM Ebi, L.P. KTT Class II 2004-04-29
K033611 CALCIGEN -NAP BONE VOID FILLER Biomet, Inc. MQV Class II 2004-04-27
K040770 VANGUARD PATELLA COMPONENTS Biomet Manufacturing, Inc. JWH Class II 2004-04-22
K034056 MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek MNH Class II 2004-04-21
K032806 KATALYST RADIAL HEAD IMPLANT Kinetikos Medical, Inc. KWI Class II 2004-04-16
K040261 REFLEX HYBRID ANTERIOR CERVICAL PLATE SYSTEM Stryker Spine KWQ Class II 2004-04-16
K032447 CANNULATED NUGEN FX SCREW FULLY THREADED, CANNULATED NUGEN FX SCREW PARTIALLY THREADED Linvatec Biomaterials, Ltd. HWC Class II 2004-04-16
K040482 EBI ESL SPINE SPACER SYSTEM Ebi, L.P. MQP Class II 2004-04-16
K033871 IM TOTAL FEMUR Biomet, Inc. JDI Class II 2004-04-16
K033961 ALTIUS OCT SYSTEM Interpore Cross Intl. KWP Class II 2004-04-14
K040331 SMITH AND NEPHEW TITANIUM INTERFERENCE SCREWS Smith & Nephew, Inc. HWC Class II 2004-04-14
K040336 SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM Synthes (Usa) HSB Class II 2004-04-12
K040762 SYNTHES (USA) TIBIAL NAIL SYSTEM EX Synthes (Usa) JDS Class II 2004-04-12
K040593 PERIARTICULAR LOCKING PLATES AND SCREWS, 2358, 2359 SERIES Zimmer, Inc. HRS Class II 2004-04-12
K040401 LANX ANTERIOR CERVIAL PLATE SYSTEM Lanx, LLC KWQ Class II 2004-04-12
K033546 NUVASIVE SPINAL SYSTEM Nuvasive, Inc. MNH Class II 2004-04-12
K033972 SCORPIO TOTAL KNEE SYSTEM Howmedica Osteonics Corp. MBH Class II 2004-04-12
K040363 CERAMIC TIPPED SKULL PIN The Jerome Group, Inc. LYT Class II 2004-04-12
K040765 SYNTHES 5.0/7.3 MM CANNULATED LOCKING SCREWS Synthes (Usa) JDW Class II 2004-04-12
K033148 ART ANTERIOR SPINAL SYSTEM Advanced Medical Technologies AG KWQ Class II 2004-04-12
K040168 MODIFICATION TO GEO STRUCTURE Interpore Cross Intl. MQP Class II 2004-04-08
K040644 MODIFICATION TO DEPUY CERAMIC FEMORAL HEAD DePuy Orthopaedics, Inc. LZO Class II 2004-04-08
K022828 OSTEOSET DBM PELLETS, MODEL 8600-48XX Wrightmedicaltechnologyinc MQV Class II 2004-04-02
K040197 EAGLE ANTERIOR CERVIAL PLATE SYSTEM Depuyacromed KWQ Class II 2004-04-02
K032534 SYNTHES AFS Synthes Spine NQW Class II 2004-04-01
K033801 KYPHX HV-R, MODEL C01A Kyphon, Inc. NDN Class II 2004-04-01
K040594 HERCULON SOFT TISSUE REATTACHMENT SYSTEM United States Surgical, A Division of Tyco Healthc HWC Class II 2004-03-31
K040583 MODIFICATION TO: CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek MNI Class II 2004-03-31
K033901 MERLIN SPINE SYSTEM Depuy Spine, Inc. NKB Class II 2004-03-31
K032717 BIOCRYL RAPIDE INTERFERENCE SCREW Mitek Worldwide HWC Class II 2004-03-31
K033702 BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM Blackstone Medical, Inc. MQP Class II 2004-03-31
K040128 MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS Howmedica Osteonics Corp. HSD Class II 2004-03-26
K040003 VERTEBRON SCP CERVICAL PLATE SYSTEM Vertebron, Inc. KWQ Class II 2004-03-26
K032730 FIXION HIP SYSTEM Disc-O-Tech Medical Technologies, Ltd. JDI Class II 2004-03-26
K040216 CERASORB M ORTHO Curasan AG MQV Class II 2004-03-26
K040130 ANTERIOR LUMBAR BUTTRESS SYSTEM Seaspine KWQ Class II 2004-03-26
K033090 ICON POLYAXIAL PEDICLE SCREW SYSTEM Alphatec Mfg., Inc. KWP Class II 2004-03-26
K040462 TRIGEN TROCHANTERIC ANTEGRADE NAIL Smith & Nephew, Inc. HSB Class II 2004-03-23

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