meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
33
Latest Decision
2007-09-17

Clearances · page 96 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K071157 STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORS Stryker Endoscopy HWC Class II 2007-09-17
K071704 SLEEVE AND BUTTON SOFT TISSUE DEVICES Biomet Sports Medicine, Inc. MBI Class II 2007-09-17
K071798 MONDEAL DISTAL RADIUS SYSTEM Mondeal Medical Systems GmbH HRS Class II 2007-09-17
K071797 MONDEAL HAND CONTOUR SYSTEM Mondeal Medical Systems GmbH HRS Class II 2007-09-17
K071877 LANX SPINAL FIXATION SYSTEM Lanx, LLC MNI Class II 2007-09-17
K072282 CAPLESS LI PEDICLE SCREW SYSTEM X-Spine Systems, Inc. MNH Class II 2007-09-14
K070742 MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM Medtronic Sofamor Danek KWP Class II 2007-09-14
K071499 COLUMBUS TOTAL KNEE SYSTEM MIOS CR/PS TIBIAL TRAY Aesculap Implant Systems, Inc. JWH Class II 2007-09-14
K071082 STRYKER MODULAR HIP SYSTEM Howmedica Osteonics Corp. LZO Class II 2007-09-13
K071437 MEGAFIX-C BIOABSORBABLE COMPOSITE INTERFERENCE SCREW, MODEL 2870719C, 2870723C, 2870823C, 2870828C, 2870928C KARL STORZ Endoscopy-America, Inc. HWC Class II 2007-09-12
K071379 DELTA XTEND REVERSE SHOULDER MODULAR STEM DePuy Orthopaedics, Inc. PHX Class II 2007-09-11
K071121 TRIBONE 80 Biomatlante MQV Class II 2007-09-11
K070554 DEPUY CORAIL AMT DYSPLASIA HIP PROSTHESIS DePuy Orthopaedics, Inc. LZO Class II 2007-09-11
K071541 SBI TWISTOFIX Small Bone Innovations, Inc. HWC Class II 2007-09-10
K071471 CORIN ADAPTOR SLEEVE Howmedica Osteonics Corp. KWL Class II 2007-09-10
K072281 NEXGEN PROLONG ALL-POLY PATELLA Zimmer, Inc. JWH Class II 2007-09-06
K070282 ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM Endius, Inc. NKB Class II 2007-09-06
K071577 BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER Biomet Microfixation, Inc. HRS Class II 2007-09-06
K072183 ST360 SPINAL FIXATION SYSTEM, MODEL 07.0029-7500.5600 Zimmer Spine, Inc. NKB Class II 2007-09-05
K072160 NEXGEN TRABECULAR METAL TIBIAL TRAY Zimmer, Inc. MBH Class II 2007-09-05
K071824 ACME TALON PEDICLE SCREW Acme Spine, LLC MNI Class II 2007-09-04
K070754 TRABECULAR METAL VERTEBRAL BODY REPLACEMENT (VBR), MODEL# 06-115, 06-155 Zimmer Trabecular Metal Technology MQP Class II 2007-08-31
K072127 DOMINATOR Biocomposites, Ltd. HWC Class II 2007-08-31
K071863 ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS) Bioretec, Ltd. HTY Class II 2007-08-31
K072132 LDR SPINE ROI-T SYSTEM Ldr Spine USA MQP Class II 2007-08-30
K063453 VERTEFIX PEDICLE SCREW SPINAL SYSTEM Elite Surgical Supplies (Pty), Ltd. MNI Class II 2007-08-30
K071852 AAP APS SYSTEM Aap Implantate AG KTT Class II 2007-08-29
K063635 SBI FOREFOOT SET Small Bone Innovations, Inc. HWC Class II 2007-08-29
K071656 SBI ARTFIX Small Bone Innovations, Inc. HWC Class II 2007-08-27
K071373 STRYKER SPINE XIA III SPINAL SYSTEM Stryker Spine NKB Class II 2007-08-27
K070787 LATITUDE ELBOW PROTHESIS Tornier JDB Class II 2007-08-24
K071274 GSO GS1 SPACER Gold Standard Orthopedics, LLC MQP Class II 2007-08-24
K071476 SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP Synthes (Usa) JEC Class II 2007-08-24
K070962 CORAL PEDICLE SCREW SYSTEM Theken Spine, LLC NKB Class II 2007-08-22
K070780 CONMED LINVATEC XO BUTTON Conmed Linvatec MBI Class II 2007-08-21
K070981 SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (PLASMAPORE) Aesculap Implant Systems, Inc. JWH Class II 2007-08-21
K071438 PSS SYSTEM Spinal USA MNI Class II 2007-08-21
K072175 TITANIUM HIP TOOL LOCKING PLATE Orthopedic Sciences, Inc. HRS Class II 2007-08-21
K071380 MODIFICATION TO SOLANAS POSTERIOR STABILIZATION SYSTEM Alphatec Spine, Inc. NKB Class II 2007-08-20
K071032 ARTHREX UNIVERS II SHOULDER PROSTHESIS Arthrex, Inc. KWS Class II 2007-08-20
K071586 BIORAPTOR 2.3 PK SUTURE ANCHOR Smith & Nephew Inc., Endoscopy Division MBI Class II 2007-08-17
K070267 DEPUY GCK TIBIAL COMPONENTS DePuy Orthopaedics, Inc. HRY Class II 2007-08-17
K071790 GENESIS II TOTAL KNEE SYSTEM, LEGION REVISION KNEE SYSTEM, JOURNEY BCS KNEE SYSTEM Smith & Nephew, Inc. MBH Class II 2007-08-17
K071738 EXACTECH OPTETRAK PROXIMAL TIBIAL SPACER Exactech, Inc. JWH Class II 2007-08-15
K071991 MODIFICATION TO SCORPIO NRG KNEE SYSTEM Howmedica Osteonics Corp. JWH Class II 2007-08-15
K062489 APEX HCLA ACETABULAR CUP LINERS Omnilife Science LPH Class II 2007-08-15
K071633 LANX DEFORMITY SYSTEM Lanx, LLC KWP Class II 2007-08-15
K071477 REVERTO 55 AND 37 SHAPE MEMORY STAPLES Core Essence Orthopaedics, LLC JDR Class II 2007-08-15
K061880 ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC Isotis NV MQV Class II 2007-08-15
K071978 MINI TIGHTROPE FT REPAIR KIT Arthrex, Inc. HTN Class II 2007-08-15
K071952 GRAFTLOCK SCREW, ST SCREW Biocomposites, Ltd. HWC Class II 2007-08-14
K071033 T2 XVBR SPINAL SYSTEM Medtronic Sofamor Danek MQP Class II 2007-08-14
K071035 IFS BONE FIXATION DEVICES Internal Fixation Systems, Inc. HWC Class II 2007-08-13
K071520 RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X Core Essence Orthopaedics, LLC MBI Class II 2007-08-10
K071944 ACUMED SMALL BONE LOCKING SYSTEM II Acumed, LLC HSB Class II 2007-08-09
K070389 PEEK KNOTLESS ANCHORS Biomet Sports Medicine, Inc. HWC Class II 2007-08-09
K071481 HEALIX ANCHOR Depuy Mitek, A Johnson & Johnson Company HWC Class II 2007-08-09
K070341 LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEM Ldr Spine USA KWP Class II 2007-08-08
K071329 NUVASIVE HELIX ACP SYSTEM Nuvasive, Inc. KWQ Class II 2007-08-08
K071540 SBI TITANIUM THREADED PIN Small Bone Innovations, Inc. JDW Class II 2007-08-08
K071563 PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM Smith & Nephew, Inc. HRS Class II 2007-08-08
K071857 DELTA SPINAL FUSION SYSTEM Jemo Spine, LLC MNI Class II 2007-08-08
K071549 SBI RHEAD PLATING SYSTEM Small Bone Innovations, Inc. HRS Class II 2007-08-07
K071377 POLARIS BE RODS Biomet Spine KWP Class II 2007-08-06
K071435 NUVASIVE OCT SYSTEM Nuvasive, Inc. MNI Class II 2007-08-06
K071637 INTRINSIC THERAPEUTICS FIXATION STAPLE Intrinsic Therapeutics Incorporated JDR Class II 2007-08-03
K071464 INION HEXALON BIODEGRADABLE ACL/PCL SCREW Inion OY HWC Class II 2007-08-03
K072040 C-JAWS CERVICAL COMPRESSIVE MINI FRAME Medicrea Technologies KWQ Class II 2007-08-03
K071176 MODIFICATION TO: ARTHREX INTERFERENCE SCREW Arthrex, Inc. MAI Class II 2007-08-03
K071479 SBI STAFIX Small Bone Innovations, Inc. JDR Class II 2007-08-02
K071417 DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES DePuy Orthopaedics, Inc. MBH Class II 2007-08-02
K071374 OPUS TWINLOCK KNOTLESS FIXATION DEVICE Arthrocare Corp. MBI Class II 2007-08-02
K071860 MODIFICATION TO: VIPER SPINE SYSTEM Depuy Spine, Inc. NKB Class II 2007-08-01
K070928 CERAMIC BALL HEADS, 28, 32 AND 36 MM Plus Orthopedics AG LZO Class II 2007-08-01
K071498 SUBTALAR IMPLANT Biomet Sports Medicine, Inc. HWC Class II 2007-07-31
K070148 GRAFT CONTAINMENT DEVICE Nuvasive, Inc. KWQ Class II 2007-07-31
K063527 MBCP+ Biomatlante MQV Class II 2007-07-30
K071031 VU E*POD VERTEBRAL BODY REPLACEMENT Theken Spine, LLC MQP Class II 2007-07-30
K071105 OSTEOMED CALCANEAL PLATE AND SCREW FIXATION SYSTEM Osteomed LP HRS Class II 2007-07-30
K071856 ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM, MODEL(S) 7848 SERIES( MODULAR NECKS), 7713 SERIES Zimmer, Inc. KWA Class III 2007-07-30
K063275 DISTAL CLAVICULAR FRAGMENT IMMOBILIZATION PLATE LEFT, MODEL 1810-116_126-03 (05,07) RIGHT 1811-116_126-03 (05,07) Terray Corp. HRS Class II 2007-07-27
K071325 BIOMET VARIABLE LOCKING PLATE SYSTEM Biomet Trauma HRS Class II 2007-07-26
K070598 MEMOMETAL INTRA-MEDULLARY BONE FASTENER, MODELS SMART TOE / X-FUSE Memometal Technologies HTY Class II 2007-07-26
K071174 PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS Abbott Spine, Inc. NKB Class II 2007-07-25
K071784 DEPUY PINNACLE WITH GRIPTON ACETABULAR CUPS DePuy Orthopaedics, Inc. LPH Class II 2007-07-25
K071583 CERMET III ACETABULAR CUP SYSTEM Implants International, Ltd. MEH Class II 2007-07-25
K070966 GSO GS1 SPINAL SYSTEM Gold Standard Orthopaedics, LLC KWP Class II 2007-07-20
K071147 NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM Nexa Orthopedics, Inc. KWT Class II 2007-07-20
K070882 STRYKER PEEK TWINLOOP TAC Stryker Endoscopy MBI Class II 2007-07-20
K071676 EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS Exactech, Inc. KWZ Class II 2007-07-19
K071715 ACUMED CONGRUENT BONE PLATE SYSTEM Acumed, LLC HRS Class II 2007-07-18
K070631 DEVICE MODIFICATION TO RADIUS SPINAL SYSTEM Stryker Spine NKB Class II 2007-07-13
K070555 ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRES Orthopro, LLC HTY Class II 2007-07-13
K070132 TRIPORE, MODELS HA, BP90, BP15 Orthogem Limited MQV Class II 2007-07-13
K071718 TRILOGY LONGEVITY CONSTRAINED LINER Zimmer, Inc. KWZ Class II 2007-07-13
K070785 DYNASTY ACETABULAR SYSTEM Wrightmedicaltechnologyinc JDL Class III 2007-07-11
K070293 BENVENUE VCF OSTEO COIL SYSTEM Benvenue Medical, Inc. OCJ Class I 2007-07-10
K063772 EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. NKB Class II 2007-07-10
K070794 ATLANTIK Medical Biomat MQV Class II 2007-07-10
K071264 SYNTHES (USA) 2.4/2.7 MM LOCKING FOOT MODULE Synthes (Usa) HRS Class II 2007-07-09

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