meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
37
Latest Decision
2012-11-08

Clearances · page 71 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K113601 AAP LOQTEQ DISTAL MEDIAL TIBIA PLATE 3.5 SYSTEM Aap Implantate AG HRS Class II 2012-11-08
K121771 ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM Zimmer, Inc. MBH Class II 2012-11-07
K122959 HAMMER TOE IMPLANT Trilliant Surgical, Ltd. HWC Class II 2012-11-07
K122738 GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET Solana Surgical, LLC HWC Class II 2012-11-07
K121277 Z-SNAP OFF SCREW, Z-DOUBLE THREAD COMPRESSION SCREW, Z-GUIDE WIRE, Z-STAPLE Z-Medical GmbH & Co. KG HWC Class II 2012-11-07
K121725 PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM Pioneer Surgical Technology, Inc. KWP Class II 2012-11-07
K121786 DYMAXEON SPINE SYSTEM B2b Spine Pty, Ltd. NKB Class II 2012-11-05
K122512 CS2 HIP SYSTEM Consensus Orthopedics, Inc. LPH Class II 2012-11-05
K121509 TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT Tgm Medical, Inc. KWY Class II 2012-11-05
K122636 REVELATION POROUS COATED HIP STEM, SIZE 8 Encore Medical L.P. LPH Class II 2012-11-02
K112700 FRONTIER SADL INTERBODY FUSION DEVICE Frontier Medical Devices, Inc. OVD Class II 2012-11-01
K113602 AAP LOQTEQ PROXIMAL LATERAL TIBIA PLATE 4.5 SYSTEM Aap Implantate AG HRS Class II 2012-10-31
K121862 REX ANTERIOR CERVICAL PLATE SYSTEM Dio Medical Co., Ltd. KWQ Class II 2012-10-31
K121732 CANOPY LAMINOPLASTY FIXATION SYSTEM Globus Medical, Inc. NQW Class II 2012-10-31
K122395 DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS DePuy Orthopaedics, Inc. HSN Class II 2012-10-31
K122314 QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY Cayenne Medical, Inc. MBI Class II 2012-10-31
K122163 CERTEX SPINAL IMPLANT SYSTEM X-Spine Systems, Inc. MNI Class II 2012-10-31
K121973 BIOPRO HEMI-EDGE TOE SYSTEM Biopro, Inc. KWD Class II 2012-10-30
K122985 COLUMBUS REVISION KNEE SYSTEM Aesculap Implant System, Inc. JWH Class II 2012-10-26
K120869 ANCHOR-L LUMBAR CAGE Stryker Spine OVD Class II 2012-10-25
K122956 FUSELOX LUMBAR INTERBODY FUSION DEVICE Captiva Spine MAX Class II 2012-10-25
K122284 HOFFMANN 3 Stryker Corp. KTT Class II 2012-10-24
K122989 BIOMET LATERAL SPACER SYSTEM Biomet Spine (Aka Ebi, LLC) MAX Class II 2012-10-24
K121636 ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT Tgm Medical, Inc. LPH Class II 2012-10-24
K122292 RELIANCE POSTERIOR CERVICAL- THORACIC SYSTEM Reliance Medical Systems, LLC KWP Class II 2012-10-24
K121312 INTRAMEDULLARY NAIL SYSTEM Weigao Orthopaedic Device Co., Ltd. HSB Class II 2012-10-24
K123012 SMITH & NEPHEW SMF HIP STEM Smith & Nephew, Inc. LPH Class II 2012-10-24
K122053 SHAPEMATCH CUTTING GUIDE Stryker Corp. MBH Class II 2012-10-24
K120832 FORTEX PEDICLE SCREW SYSTEM X-Spine Systems, Inc. MNH Class II 2012-10-23
K121815 NUVASIVE SAGE LATERAL PLATE SYSTEM Nuvasive, Inc. KWQ Class II 2012-10-23
K122533 OSSEOFLEX SB INFLATABLE BONE TAMP Osseon Therapeutics, Inc. NDN Class II 2012-10-23
K123019 LONGEVITY IT HIGHLY CROSSLINKED POLYETHYENE LINERS Zimmer, Inc. LPH Class II 2012-10-22
K122382 DYNASTY BIOFOAM SHELL Wrightmedicaltechnologyinc MBL Class II 2012-10-22
K122277 OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM Biomet Manufacturing Corp HRY Class II 2012-10-22
K121876 VERTECEM II CEMENT KIT Aap Biomaterials GmbH NDN Class II 2012-10-19
K122911 VERSAFITCUP CC TRIO EXTENSION Medacta International LZO Class II 2012-10-19
K122170 SMITH & NEPHEW, INC. INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATION Smith & Nephew, Inc. HSB Class II 2012-10-19
K113219 ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM Ellipse Technologies, Inc. HSB Class II 2012-10-19
K122896 COUGAR LS 15 LATERAL CAGE SYSTEM Medos International SARL MAX Class II 2012-10-18
K121741 4-WEB CERVICAL STS (SPINAL TRUSS SYSTEM) 4-Web, Inc. ODP Class II 2012-10-18
K122085 STINGRAY CERVICAL CAGE Omni Surgical, LP Dba Spine360 ODP Class II 2012-10-17
K121581 BOX PEEK VBR SYSTEM, Innovasis, Inc. MAX Class II 2012-10-17
K122139 SMITH & NEPHEW R3 CONSTRAINED LINERS Smith & Nephew, Inc. KWZ Class II 2012-10-16
K122332 TOWERLOX PEDICLE SCREW SYSTEM Captiva Spine MNI Class II 2012-10-16
K121627 SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEM Smith & Nephew, Inc. MEH Class II 2012-10-15
K122497 ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 14MM ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 16MM Medical Design, LLC KWQ Class II 2012-10-15
K120595 UNISYN PLUS HIP STEM Consensus Orthopedics, Inc. LWJ Class II 2012-10-12
K121651 ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM Wrightmedicaltechnologyinc HRS Class II 2012-10-12
K122293 PIONEER STERNAL CABLE PLATE SYSTEM Pioneer Surgical Technology, Inc. HRS Class II 2012-10-12
K122074 IFUSE IMPLANT SYSTEM SI-BONE, Inc. OUR Class II 2012-10-12
K111981 TREGOR DUAL MOBILITY ACETABULAR SYSTEM Aston Medical LZO Class II 2012-10-12
K122910 ARCHON ANTERIOR CERVICAL PLATE SYSTE, Nu Vasive, Incorporated KWQ Class II 2012-10-11
K122233 CAPSURE(R) PS SYSTEM Spine Wave, Inc. MNI Class II 2012-10-11
K122778 PROFEMUR Z REVISION HIP STEM Wrightmedicaltechnologyinc KWA Class III 2012-10-11
K121543 ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, BASE PLATES & HUMERAL STEMS Zimmer, Inc. KWT Class II 2012-10-11
K122798 INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL Exactech, Inc. LPH Class II 2012-10-11
K122168 VISUALIF CHALLENGING ACCESS PLATE Spine Smith Partners L.P. OVD Class II 2012-10-11
K122463 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W Cayenne Medical, Inc. MBI Class II 2012-10-11
K122504 FEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTH United Orthopedic Corporation LPH Class II 2012-10-10
K122031 NEXTRA TI HAMMERTOE CORRECTION SYSTEM Nextremity Solutions, LLC HWC Class II 2012-10-09
K122773 CROSS-OVER ACETABULAR SHELL & LINER Stelkast Company OQG Class II 2012-10-09
K112837 VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE) Vilex, Inc. JDR Class II 2012-10-09
K120401 ALAMO T Alliance Partners, LLC MAX Class II 2012-10-05
K121728 TIGER SPINE SYSTEM Corelink, LLC NKB Class II 2012-10-05
K113039 SMITH & NEPHEW RADIOPAQUE TRIAL NECKS Smith & Nephew, Inc. MEH Class II 2012-10-05
K121563 CORIN TRIFIT TS HIP Corin USA MEH Class II 2012-10-05
K122099 BENCOX II STEM, BENCOX METAL HEAD Corentec Co., Ltd. LPH Class II 2012-10-05
K121682 ACTIVE SCREW BONE SCREW Intelligent Implant Systems, LLC HWC Class II 2012-10-04
K122366 TRYPTIK CC ANTERIOR INTERSOMATIC CERVICAL CAGE Spineart ODP Class II 2012-10-04
K122737 GEMINUS FOSSA SPECIFIC PLATE SYSTEM Skeletal Dynamics, LLC HRS Class II 2012-10-03
K122862 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. NKB Class II 2012-10-03
K122228 LIGAFIX INTERFERENCE SCREW Sbm Sciences For Bio Materials MAI Class II 2012-10-03
K122123 6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPERED Depuy Mitek, Inc., A Johnson and Johnson Company MBI Class II 2012-10-02
K120148 AOS SOLID LOCKING LAG SCREW, AOS TELESCOPING LAG SCREW Advanced Orthopaedic Solutions, Inc. HSB Class II 2012-10-02
K120998 SOLSTICE CROSS CONNECTOR Life Spine KWP Class II 2012-10-01
K121684 NOVATION LPI PRIME FEMORAL STEM Exactech, Inc. LPH Class II 2012-10-01
K120891 TANGORS MULTIFUNCTIONAL POSTERIOR SYSTEM Ulrich GmbH & Co. KG NKB Class II 2012-10-01
K121672 AFT PROXIMAL HUMERUS FRACTURE PLATE Shoulder Options, Inc. HRS Class II 2012-10-01
K122308 AXSOS DISTAL LATERAL FEMUR TS LONG PLATES Howmedica Osteonics Corp., Dba Stryker Orthopaedics HRS Class II 2012-10-01
K121425 ORTHOLOC 3DI ANKLE FUSION PLATING SYSTEM Wrightmedicaltechnologyinc HRS Class II 2012-10-01
K122226 REVERE STABILIZATION SYSTEM Globus Medical, Inc. NKB Class II 2012-10-01
K122641 MPACT EXTENSION Medacta International LZO Class II 2012-09-28
K122232 GMK NARROW Medacta International JWH Class II 2012-09-28
K122433 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek, Inc. NKB Class II 2012-09-28
K121713 PMT BONE SCREWS Providence Medical Technology, Inc. HWC Class II 2012-09-27
K122033 ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM Conformis, Inc. JWH Class II 2012-09-27
K122623 SHORT LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT MODEL 3017-000 (LEFT) AND 3018-000 (RIGHT); 6 HOLE MEDIUM MIDSHAFT Advanced Orthopaedic Solutions, Inc. HRS Class II 2012-09-26
K121567 ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM Accel Spine MAX Class II 2012-09-26
K121665 BENCOX FORET & BENCOX DELTA Corentec Co., Ltd. LZO Class II 2012-09-25
K120943 SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT SPEEDLOCK HIP DRILL SPEEDLOCK HIP GUIDE CROWN TIP SPEEDLOCK HIP PATHFINDER ArthroCare Corporation MBI Class II 2012-09-21
K121568 DALI SPINAL FIXATION SYSTEM Accel Spine NKB Class II 2012-09-21
K122021 STERISPINE LC CAGE Safe Orthopaedics MAX Class II 2012-09-20
K122541 ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) Orthofix Srl KTW Class II 2012-09-20
K122378 NEXTGEN ALTIUS OCT SYSTEM Biomet Spine (Aka Ebi, LLC) KWP Class II 2012-09-20
K121056 METS MODULAR PROXIMAL FEMUR Stanmore Implants Worldwide , Ltd. JDI Class II 2012-09-20
K121302 BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM Biomet Microfixation HRS Class II 2012-09-19
K121055 METS MODULAR TOTAL FEMUR Stanmore Implants Worldwide , Ltd. JDI Class II 2012-09-19
K121029 METS MODULAR DISTAL FEMUR Stanmore Implants Worldwide , Ltd. KRO Class II 2012-09-19
K122622 ENDURAMESH Lucero Medical, LLC MQP Class II 2012-09-19
K122591 CLYDESDALE SPINAL SYSTEM Medtronic Sofamor Danek, Inc. MAX Class II 2012-09-18

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