meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
33
Latest Decision
2010-08-24

Clearances · page 83 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K102235 MANTIS SPINAL SYSTEM & MANTIS REDUX SPINAL SYSTEM Stryker Spine NKB Class II 2010-08-24
K100841 BONEOPTIMIZER Curasan AG MQV Class II 2010-08-19
K101704 ZIMMER DTO PIN PRESS INSTRUMENT Zimmer Spine, Inc. NQP Class II 2010-08-18
K100354 PRIMAL OK INTERSPINOUS FUSION SYSTEM Osteomed LP KWP Class II 2010-08-17
K094043 LIGAMENTOTAXOR Arex USA HTY Class II 2010-08-17
K100970 STAINLESS STEEL SPINAL SYSTEM Theken Spine, LLC NKB Class II 2010-08-12
K101051 AVS A-LAT PEEK SPACERS, MODELS 48750XXX, 48751XXX, 48752XXX, 48753XXX Stryker Spine MAX Class II 2010-08-12
K093828 KYPH X HV-R BONE CEMENT Medtronic, Inc. NDN Class II 2010-08-12
K093692 QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES Pioneer Surgical Technology NKB Class II 2010-08-11
K100865 AVA NAVIGATOR PEEK SPACERS, MODEL 48392XXX, 48393XXX Stryker Spine MAX Class II 2010-08-11
K100973 EVOLUTION UNICONDYLAR KNEE SYSTEM Wrightmedicaltechnologyinc HRY Class II 2010-08-10
K093771 QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM Pioneer Surgical Technology MNH Class II 2010-08-10
K100743 ATLAS SPINE PIVOTING SYSTEM Atlas Spine, Inc. MAX Class II 2010-08-10
K100935 LANX SPINAL FIXATION SYSTEM Lanx, Inc. NKB Class II 2010-08-06
K100952 MODIFICATION TO SYNTHES MATRIX SYSTEM Synthes Spine NKB Class II 2010-08-05
K093868 I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM I.T.S. Implantat-Technologie-Systeme GmbH HRS Class II 2010-08-05
K100820 WENZEL SPINE VARILIFT INTERBODY FUSION SYSTEM Wenzel Spine MAX Class II 2010-08-05
K100776 SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM Synthes (Usa) HRS Class II 2010-08-03
K092721 ALIGN RADIAL HEAD SYSTEM Skeletal Dynamics, LLC KWI Class II 2010-08-03
K101981 OPTETRAK LOGIC COMBINATION TIBIAL TRAY Exactech, Inc. JWH Class II 2010-08-02
K100851 RANGE SPINAL SYSTEM K2m, Inc. MNI Class II 2010-08-02
K100741 REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/012 Encore Medical L.P. PHX Class II 2010-08-02
K101909 EXACTECH EQUINOXE, PLATFORM FRACTURE STEM Exactech, Inc. PHX Class II 2010-08-02
K100502 ASCENSION TOTAL PLATE SYSTEM Ascension Orthopedics, Inc. HRS Class II 2010-08-02
K101296 ZIMMER SEGMENTAL SYSTEM PROXIMAL FEMORAL COMPONENT AND SMALL DIAMETER STEM EXTENSIONS Zimmer, Inc. LZO Class II 2010-07-30
K101281 VEGA KNEE SYSTEM Aesculap Implant System, Inc. JWH Class II 2010-07-30
K093342 BIOGENNIX RPC Biogennix, LLC MQV Class II 2010-07-29
K100889 ENDOSKELETON TC Titan Spine, LLC ODP Class II 2010-07-29
K101678 ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM Spineart MNH Class II 2010-07-28
K093926 FIREBIRD SPINAL FIXATION SYSTEM Blackstone Medical, Inc. NKB Class II 2010-07-28
K101206 TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY (TGS UKA) MODULAR TIBIA SYSTEM Alexandria Research Technologies, LLC HSX Class II 2010-07-23
K100147 S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM Aesculap Implant System, Inc. NKB Class II 2010-07-23
K101165 PRO-TOE VO HAMMERTOW IMPLANT SYSTEM Wrightmedicaltechnologyinc HWC Class II 2010-07-23
K101240 CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467 DePuy Orthopaedics, Inc. HRS Class II 2010-07-23
K101302 ALEUTIAN IBF SYSTEM K2m, Inc. ODP Class II 2010-07-22
K100706 VENUS BASIC SPINAL FIXATION SYSTEM L&K BIOMED Co., Ltd. MNH Class II 2010-07-22
K100544 IMPIX LUMBAR INTERBODY DEVICE Medicrea Technologies MAX Class II 2010-07-22
K101255 ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEM Alphatec Spine, Inc. KWQ Class II 2010-07-21
K100802 AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM Aesculap Implant Systems, Inc. OVD Class II 2010-07-20
K100805 GALLERY LAMINOPLASTY FIXATION SYSTEM Biomet Spine (Aka Ebi, LLC) NQW Class II 2010-07-20
K100986 CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEO VATION Skeletal Kinetics, LLC MQV Class II 2010-07-20
K100765 FIXPINE II SYSTEM Dio Medical Co., Ltd. MNI Class II 2010-07-19
K101720 JULIET OL Spineart MAX Class II 2010-07-16
K101254 NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM Tecnologia Y Diseno Industrial, S.A DE C.V HWC Class II 2010-07-15
K100481 SMITH & NEPHEW MDF MODULAR SLEEVE Smith & Nephew, Inc. MEH Class II 2010-07-15
K100925 ASCENSION ANKLE FUSION NAIL SYSTEM Ascension Orthopedics, Inc. HSB Class II 2010-07-12
K100956 SPONDY SPINAL FIXATION SYSTEM Allure Spine LLC MNH Class II 2010-07-09
K101032 CARDO MEDICAL FEMORAL CEMENT RESTRICTOR, MODEL 503-MCRX Cardo Medical, Inc. JWH Class II 2010-07-08
K101144 MODIFICATION TO:RADIUS SPINAL SYSTEM Stryker Spine NKB Class II 2010-07-08
K101083 DSS STABILIZATION SYSTEM Paradigm Spine, LLC NQP Class II 2010-07-02
K100414 PROTOE ENDOSORB SMALL HAMMER TOE PIN Merete Medical GmbH JDW Class II 2010-07-02
K101085 SPINESMITH CYNCH SPINAL SYSTEM Spine Smith Partners L.P. MAX Class II 2010-07-01
K101557 GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN Etex Corp. MQV Class II 2010-07-01
K100757 TILOCK PEDICLE SCREW SYSTEM Genesys Spine NKB Class II 2010-07-01
K100634 SYNTHES MATRIX SYSTEM Synthes (Usa) NKB Class II 2010-07-01
K101575 APEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810, 303210,303610,304010 Omnlife Science LPH Class II 2010-06-30
K100373 TYCHE PEDICLE SCREW SYSTEM Kyung Won Medical Co., Ltd. MNH Class II 2010-06-30
K094042 PEEK PREVAIL CERVICAL INTERBODY DEVICE Medtronic Sofamor Danek OVE Class II 2010-06-30
K092815 S-LIF INTERVERTEBRAL BODY FUSION DEVICE Spinefrontier, Inc. MAX Class II 2010-06-30
K092720 WRIST ARTHRODESIS NAIL SYSTEM Skeletal Dynamics, LLC HSB Class II 2010-06-29
K100562 LATITUDE ELBOW PROSTHESIS Tornier, Inc. JDB Class II 2010-06-29
K092889 SYNTEC OSTEO-PLATE AND SCREW FIXATION Syntec Scientific Corp. HRS Class II 2010-06-25
K100707 REPROCESSED PINS Sterilmed, Inc. NDM Class II 2010-06-25
K093104 MEDYSSEY CO., LTD., ZENIUS SPINAL SYSTEM Medyssey Co, Ltd. MNI Class II 2010-06-25
K100214 CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE Medtronic Sofamor Danek ODP Class II 2010-06-25
K100542 CONSENSUS REVISION KNEE SYSTEM Consensus Orthopedics, Inc. JWH Class II 2010-06-24
K100359 DARCO HEADED CANNULATED SCREW Wrightmedicaltechnologyinc HWC Class II 2010-06-24
K100438 POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM Ebi, L.P. NKB Class II 2010-06-23
K100409 POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEM Biomet Spine (Aka Ebi, LLC) NKB Class II 2010-06-23
K101063 SLEEVE WITH ZIPLOOP FIXATION DEVICES Biomet Sports Medicine MBI Class II 2010-06-23
K093707 DYNA LOCKING TROCHANTERIC NAIL, MODEL NG0820 U&I Corp. HSB Class II 2010-06-23
K100652 ACL TIGHTROPE Arthrex, Inc. HTY Class II 2010-06-23
K093078 UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORS Bonutti Research, Inc. HWC Class II 2010-06-23
K093319 NUVASIVE VUEPOINT OCT SYSTEM Nuvasive, Inc. KWP Class II 2010-06-23
K091912 B-GENIN AND R-GENIN Berkeley Advanced Biomaterials, Inc. MQV Class II 2010-06-23
K101074 MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. NKB Class II 2010-06-22
K101451 APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD Omni Life Science, Inc. LZO Class II 2010-06-22
K100497 QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM) N.M.B. Medical Applications, Ltd. HSB Class II 2010-06-21
K101448 OPUS SPEEDSCREW SYSTEM Arthrocare Corp. MBI Class II 2010-06-21
K100685 ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM Alphatec Spine, Inc. KWP Class II 2010-06-18
K100900 MOTIVATION KNEE SYSTEM Encore Medical L.P. JWH Class II 2010-06-18
K101475 COMPRESS ANTI-ROTATION SPINDLES Biomet Manufacturing Corp KWA Class III 2010-06-18
K101438 T2 GREATER TROCHANTER NAIL Howmedica Osteonics Corp. HSB Class II 2010-06-17
K100043 COROENT XLR STANDALONE SYSTEM Nuvasive, Inc. OVD Class II 2010-06-16
K100176 ASCENSION ANKLE FUSION PLATE SYSTEM Ascension Orthopedics, Inc. HRS Class II 2010-06-16
K101421 MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OLECRANON PLATES MODEL 131218704-708; 851318704-708, 131218204 DePuy Orthopaedics, Inc. HRS Class II 2010-06-15
K100604 OTIS -C PLUS Sciences ET Bio Materiaux (Sbm) HRS Class II 2010-06-14
K100981 UNITED STEM, PSA TYPE United Orthopedic Corp. JWH Class II 2010-06-14
K100630 G-FORCE PEEK SUTURE ANCHOR SYSTEM Wrightmedicaltechnologyinc MBI Class II 2010-06-11
K093442 GUIDED GROWTH SYSTEM Orthofix, Inc. OBT Class II 2010-06-10
K100137 SIDEKICK CIRCULAR FIXATOR SYSTEM: STRUTS AND HINGES Wrightmedicaltechnologyinc KTT Class II 2010-06-10
K100623 AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEM Aesculap Implant Systems NKB Class II 2010-06-09
K100605 MIS SYSTEM Spine Wave, Inc. MNH Class II 2010-06-04
K100708 PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES Pioneer Surgical Technology KWQ Class II 2010-06-04
K101030 MODIFICATION TO HBS HEADLESS BONE SCREW Biopro, Inc. HWC Class II 2010-06-03
K100175 CLYDESDALE SPINAL SYSTEM Medtronic Sofamor Danek MAX Class II 2010-06-02
K100151 APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM) Omnlife Science KWY Class II 2010-05-28
K092608 SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX Collagen Matrix, Inc. MQV Class II 2010-05-28
K093275 EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM 36MM GLENOSPHERE AND HUMERAL LINER Exactech, Inc. PHX Class II 2010-05-27
K100269 NOVATION CROWN CUP GXL LINERS Exactech, Inc. LPH Class II 2010-05-27

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