meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
26
Latest Decision
2002-09-17

Clearances · page 118 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K022515 BIOMET CALCANEAL PLATE Biomet Orthopedics, Inc. HRS Class II 2002-09-17
K022324 NORMED TITANIUM CALCANEUS PLATING WITH LOCKING SCREW SYSTEM Osteomedics, Inc. HRS Class II 2002-09-17
K022423 EXTERNAL FIXATION RING Rigid FX Orthopedics, Incorporated KTT Class II 2002-09-17
K022231 NORMED DISTAL RADIUS RECONSTRUCTION SYSTEM Osteomedics, Inc. HRS Class II 2002-09-13
K022981 INION CPS 2.5/2.8 SCREW Inion , Ltd. HWC Class II 2002-09-12
K021623 UCR SPINAL SYSTEM, 5.5MM, 8.0MM SCREWS & INSTRUMENTS Iame, Inc. MNH Class II 2002-09-10
K022230 NORMED MINI EXTERNAL FIXATOR SYSTEM Osteomedics, Inc. HRS Class II 2002-09-10
K022325 NORMED TITANIUM OSTEOTOMY PLATING SYSTEM Osteomedics, Inc. HRS Class II 2002-09-09
K022323 NORMED TITANIUM RONDO FIX FUSION PLATES AND SCREW SYSTEM Osteomedics, Inc. HRS Class II 2002-09-09
K021932 SYNTHES 6.5 MM CANNULATED SCREW Synthes (Usa) HWC Class II 2002-09-06
K022726 STAYFUSE GT-IP Pioneer Surgical Technology HWC Class II 2002-09-06
K020345 ARTHREX UNIVERS FRACTURE PROSTHESIS Arthrex, Inc. KWS Class II 2002-09-06
K011531 CALCIUM PHOSPHATE GRANULAR BONE VOID FILLER Biomet, Inc. MQV Class II 2002-09-06
K021891 ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM Zimmer, Inc. LPH Class II 2002-09-05
K022647 HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, MODEL 7.3MM Triad Medical, Inc. HWC Class II 2002-09-05
K022563 HYDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1 Implex Corp. MQP Class II 2002-08-30
K022556 REFLECTION MODIFIED ACETABULAR SHELLS Smith & Nephew, Inc. LPH Class II 2002-08-28
K022191 MODIFICATION TO TENOR SPINAL SYSTEM Medtronic Sofamor Danek, Inc. KWP Class II 2002-08-28
K022623 5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM) Depuyacromed KWP Class II 2002-08-27
K021791 VERTE-STACK SPINAL SYSTEM Medtronic Sofamor Danek MQP Class II 2002-08-26
K021933 TEMPFIX EXTERNAL FIXATION SYSTEM DePuy Orthopaedics, Inc. KTT Class II 2002-08-26
K022711 MODIFICATION TO AVALON CUP SYSTEM Orthopedic Source, Inc. LPH Class II 2002-08-26
K021782 BNF Aap Implantate AG JDS Class II 2002-08-26
K021786 TITANIUM ANKLE ARTHRODESIS NAIL Biomet, Inc. HSB Class II 2002-08-26
K022481 S2 TIBIAL NAIL Howmedica Osteonics Corp. HSB Class II 2002-08-26
K022531 2MM PEDIATRIC FLEX NAIL Biomet, Inc. HTY Class II 2002-08-26
K022555 ACCOLADE C FEMORAL STEMS Howmedica Osteonics Corp. LZO Class II 2002-08-26
K022437 UNI KNEE Encore Medical L.P. HRY Class II 2002-08-23
K022578 ENDIUS FLEXTIP BLADE Endius, Inc. HRX Class II 2002-08-23
K022461 S2 FEMORAL NAIL Howmedica Osteonics HSB Class II 2002-08-22
K022605 BLACKSTONE SPINAL FIXATION SYSTEM STAPLE & WASHER Blackstone Medical, Inc. KWQ Class II 2002-08-21
K022010 TOTAL KNEE FEMORAL COMPONENT Smith & Nephew, Inc. JWH Class II 2002-08-19
K022463 HA MODULAR REACH PROXIMAL POROUS AND HA MODULAR REACH COLLARED PROXIMAL POROUS FEMORAL STEMS Biomet Orthopedics, Inc. LPH Class II 2002-08-16
K022586 ANTERIOR STABILIZED TIBIAL BEARINGS Biomet Orthopedics, Inc. JWH Class II 2002-08-15
K022285 MODIFICATION TO ISOLA SPINAL SYSTEM Depuyacromed MNI Class II 2002-08-13
K021662 MAGLY 6.5MM CANNULATED SCREWS Magly Orthopedics, LLC HWC Class II 2002-08-12
K022319 EBI XFIX DFS SYSTEM Ebi, L.P. KTT Class II 2002-08-12
K021749 EBI DYNAFIX VS OSTEOTOMY SYSTEM Ebi, L.P. NDF Class II 2002-08-12
K021657 UKNEE TOTAL KNEE SYSTEM United Orthopedic Corp. JWH Class II 2002-08-12
K022419 EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM Ebi, L.P. KWQ Class II 2002-08-12
K021626 HALLU PLATES New Deal, S.A. HRS Class II 2002-08-12
K021556 SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW Synthes (Usa) HWC Class II 2002-08-09
K021578 NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE Sulzer Orthopedics, Inc. JWH Class II 2002-08-09
K021579 MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM Magly Orthopedics, LLC HWC Class II 2002-08-09
K022065 SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X Sintea Biotech, Inc. JEC Class II 2002-08-06
K022399 BLACKSTONE SPINAL FIXATION SYSTEM SPACER Blackstone Medical, Inc. KWQ Class II 2002-08-06
K021507 PLUS PIVOT LINK UNIVERSAL SYSTEM Spine Vision, Inc. KWP Class II 2002-08-01
K021549 CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM Std Mfg., Inc. KXA Class II 2002-08-01
K021510 UNI-T UNI-THREAD SPINAL SYSTEM Spine Vision, Inc. MNI Class II 2002-08-01
K022160 XIA SPINAL SYSTEM Howmedica Osteonics MNI Class II 2002-08-01
K014070 EPOCH HIP PROSTHESIS, MODEL 4075 SERIES Zimmer, Inc. LPH Class II 2002-07-30
K021881 ENDIUS TITLE SPINAL FIXATION SYSTEM Endius, Inc. MNH Class II 2002-07-29
K020222 WISORB MALLEOLAR SCREW Cambridge Scientific, Inc. HWC Class II 2002-07-29
K022094 PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING Biomet, Inc. JDI Class II 2002-07-25
K021336 NOVABONE-RESORBABLE BONE GRAFT SUBSTITUTE Novabone Products, LLC MQV Class II 2002-07-25
K022255 MODOFOCATION TO SYNTHES ANKLE ARTHRODESIS PLATES Synthes (Usa) HRS Class II 2002-07-25
K022225 VECTOR MEDICAL, INC., VECTOR TARGETING SYSTEM Vector Medical, Inc. HSB Class II 2002-07-25
K021061 MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek KWP Class II 2002-07-25
K022077 36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT) Howmedica Osteonics Corp. JDI Class II 2002-07-25
K021458 SYNTHES IN-SITU BENDER/CUTTER Synthes (Usa) HRS Class II 2002-07-24
K022190 MODIFICATION TO SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM Depuyacromed MNI Class II 2002-07-24
K021466 CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE Hayes Medical, Inc. LPH Class II 2002-07-24
K021499 CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 BONE CEMENT DePuy Orthopaedics, Inc. LOD Class II 2002-07-24
K022120 MPF ACETABULAR CUP GENERATION 2 Plus Orthopedics LZO Class II 2002-07-24
K020356 ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM Alphatec Mfg., Inc. MNH Class II 2002-07-23
K021822 R120 MODULAR TOTAL HIP SYSTEM Osteoimplant Technology, Inc. JDI Class II 2002-07-23
K020172 OPUS MAGNUM ANCHOR & INSTRUMENT SET Opus Medical, Inc. MBI Class II 2002-07-22
K022070 XANTUS ANTERIOR LATERAL SUPPLEMENTAL FIXATION SYSTEM Medtronic Sofamor Danek, Inc. KWP Class II 2002-07-22
K021313 SEARCH EVOLUTION TOTAL KNEE SYSTEM Aesculap, Inc. JWH Class II 2002-07-22
K021461 ATLANTIS VISION ANTERIOR CERVICAL PLATE SYSTEM Medtronic Sofamor Danek KWQ Class II 2002-07-22
K020986 MASTERGRAFT RESORBABLE CERAMIC Medtronic Sofamor Danek, Inc. MQV Class II 2002-07-22
K020247 COLORADO 2 SPINAL SYSTEM Medtronic Sofamor Danek, Inc. MNH Class II 2002-07-22
K021275 MICOMED POSTERIOR DOUBLEROD SYSTEM Micomed Ortho GmbH MNI Class II 2002-07-18
K022015 MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM Medtronic Sofamor Danek, Inc. KWP Class II 2002-07-18
K021967 HEDROCEL VERTEBRAL BODY REPLACEMENT, MODELS 06-112-00XX2 AND 06-132-10XX2 Implex Corp. MQP Class II 2002-07-17
K013906 HLS NOETOS SYSTEM Tornier JWH Class II 2002-07-17
K021280 INION HEXALON BIODEGRADABLE ACL/PCL SCREW Inion , Ltd. HWC Class II 2002-07-17
K021321 WRIST FUSION PLATE Acu Med, Inc. HRS Class II 2002-07-17
K021254 LACTOSORB MINI INTERFERENCE SCREW Biomet Orthopedics, Inc. HWC Class II 2002-07-17
K021970 THE TRABECULAR METAL MONOBLOCK CUP, MODELS 00-7259-0XX-28 (ZIMMER CAT. #) AND 02-293-28XX1 (IMPLEX PART #) Implex Corp. LPH Class II 2002-07-12
K020114 3D KNEE Encore Orthopedics, Inc. JWH Class II 2002-07-12
K021335 MONARCH SPINE SYSTEM Depuyacromed MNH Class II 2002-07-11
K012193 AMC ANTIMICROBIAL PIN/WIRE SLEEVE Smith & Nephew, Inc. JEC Class II 2002-07-11
K021908 PROVEN MODULAR POSTERIOR STABILIZED FEMORAL Stelkast Company JWH Class II 2002-07-09
K021170 TSRH SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. KWP Class II 2002-07-09
K021919 SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDIUM, MODEL CO05, SCS CLARIS SPINAL SYSTEM,EXTENDED OMNIAXIALO Ortho Tec, LLC KWP Class II 2002-07-03
K021911 TRIDENT CROSSFIRE POLYUETHYLENE LINERS Howmedica Osteonics Corp. LPH Class II 2002-07-02
K021346 STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX Wrightmedicaltechnologyinc LPH Class II 2002-07-02
K021828 SMALL HAMMER TOE PIN Biomet, Inc. HWC Class II 2002-07-01
K021825 MODIFICATION TO SPIRAL RADIUS 90-D SST SYSTEM Unitedstates Surgical KWP Class II 2002-07-01
K021883 BIOFASTIN RC THREADED SUTURE ANCHOR Mitek Worldwide HWC Class II 2002-07-01
K021164 MACROPORE OS TRAUMA Macropore Biosurgery, Inc. HRS Class II 2002-07-01
K011037 VERTEBRAL SPACER Synthes (Usa) MQP Class II 2002-07-01
K021349 METAL TRANSCEND ARTICULATION SYSTEM (LARGER SIZES) Wrightmedicaltechnologyinc KWA Class III 2002-07-01
K021063 GREAT TOE IMPLANT Signal Medical Corp. KWD Class II 2002-07-01
K021748 ENDIUS ATAVI SYSTEM Endius, Inc. HRX Class II 2002-06-26
K021799 CEMENTED FEMORAL HEAD RESURFING DEVICE Biomet Orthopedics, Inc. KXA Class II 2002-06-26
K020056 DUET SUTURE ANCHOR Bionx Implants, Ltd. HWC Class II 2002-06-26
K021879 CROSSOVER CROSS CONNECTOR (ISOLA SPINAL SYSTEM) Depuyacromed MNH Class II 2002-06-26
K021832 ARTHROTEK RESORBABLE NO-PROFILE LACTOSORB L-15 SCREW & WASHER Biomet, Inc. HWC Class II 2002-06-26

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