meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
33
Latest Decision
2012-09-18

Clearances · page 72 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K110949 BICERA (TM) RESORBABLE BONE SUBSTITUTE Wiltrom Corporation Limited MQV Class II 2012-09-18
K113742 KMC KYPHOPLASTY SYSTEM Shanghai Kinetic Medical Co., Ltd. NDN Class II 2012-09-17
K113296 ZMR HIP SYSTEM KWZ-PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER Zimmer, Inc. LPH Class II 2012-09-14
K121439 METAFIX FEMORAL HIP STEM SIZE 1 Corin USA LZO Class II 2012-09-14
K121575 OXFORD ANKLE FUSION NAIL(AFN) SYSTEM Ortho Solutions Limited HSB Class II 2012-09-14
K121078 VAN GOGH ANTERIOR CERVICAL PLATE SYSTEM Accel Spine KWQ Class II 2012-09-13
K121541 JAZZ SYSTEM Implanet, S.A. JDQ Class II 2012-09-13
K121630 RANGE SPINAL SYSTEM K2m, Inc. OSH Class II 2012-09-11
K122352 NUVASIVE PRECEPT SPINAL SYSTEM Nuvasive, Inc. NKB Class II 2012-09-11
K121801 QUINTEX CERVICAL PLATING SYSTEM Aesculap Implant Systems, LLC KWQ Class II 2012-09-11
K120924 BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX MIRABO CUP SCREW HOLE PLUG Corentec Co., Ltd. LPH Class II 2012-09-10
K121316 LANX SPINAL FIZATION SYSTEM Lanx, Inc. NKB Class II 2012-09-10
K113060 UNITY TOATAL KNEE SYSTEM Corin USA JWH Class II 2012-09-10
K121935 TAPERSET HIP SMALL STEMS Consensus Orthopedics, Inc. LPH Class II 2012-09-10
K121714 SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS Smith & Nephew, Inc. HSD Class II 2012-09-07
K113648 LOQTEQ LARGE FRAGMENT SET LOQTEQ CORTICAL SCREW 4.5, SMALL HEAD, T25, SELF TAPPING LOQTEQ CORTICAL SCREW 4.5, T25, SELF Aap Implantate AG HRS Class II 2012-09-06
K122442 DEPUY CTA REVERSE SHOULDER SYSTEM Depuy France PHX Class II 2012-09-06
K122005 MAXLOCK EXTREME SYSTEM Orthohelix Surgical Designs, Inc. HRS Class II 2012-09-06
K121974 CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM Conformis, Inc. HSX Class II 2012-09-06
K120992 METS SMILES TOTAL KNEE REPLACEMENT Stanmore Implants Worldwide , Ltd. KRO Class II 2012-09-05
K122216 RELIANCE ANTERIOR CERVICAL PLATE SYSTEM Reliance Medical Systems, LLC KWQ Class II 2012-09-05
K121034 IOI TOTAL HIP Iconacy Orthopedic Implants, LLC LPH Class II 2012-09-04
K113770 ORTHOFIX GALAXY FIXATION SYSTEM Orthofix Srl KTT Class II 2012-09-04
K122047 ALAMO P Alliance Partners, LLC MAX Class II 2012-09-04
K120819 STALIF C Centinel Spine, Inc. OVE Class II 2012-08-31
K122444 CERVICAL CAGE Eisertech, LLC ODP Class II 2012-08-30
K113652 LOQTEQ SMALL FRAGMENT SET LOQTEQ CORTICAL SCREW3.5, SMALL HEAD, T15, SELF TAPPING LOQTEQ CORTICAL SCREW 3.5, T15, SELF T Aap Implantate AG HRS Class II 2012-08-30
K122317 TETRIS II Signus Medizintechnik GmbH MAX Class II 2012-08-29
K121276 NEURO VENTION LAMINPLASTY PLATING SYSTEM Neurovention, LLC NQW Class II 2012-08-29
K121889 STAXX XD SYSTEM Spine Wave, Inc. MQP Class II 2012-08-29
K121760 CAPSTONE SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. MAX Class II 2012-08-29
K122296 SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATING Smith & Nephew, Inc. LZO Class II 2012-08-28
K121482 INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY Theken Spine, LLC HRX Class II 2012-08-28
K113666 XIA 3 SPINAL SYSTEM Stryker Spine NKB Class II 2012-08-28
K121619 NUVASIVE POLYAXIAL SPINAL SCREWS Nuvasive, Inc. NKB Class II 2012-08-24
K121892 PHANTOM PLUS CERAMIC CAGE SYSTEM Amedica Corp. MAX Class II 2012-08-24
K121103 LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT S Ldr Spine USA, Inc. NKB Class II 2012-08-24
K120906 ZIMMER TRABECULAR METAL TOTAL ANKLE Zimmer, Inc. HSN Class II 2012-08-24
K120991 TRANS1 INTERBODY FUSION SYSTEM Trans1 Incorporated MAX Class II 2012-08-23
K122244 POLARCUP DUAL MOBILITY SYSTEM Smith & Nephew, Inc. LPH Class II 2012-08-23
K121890 GENESYS PRESSFT SUTURE ANCHOR Linvatec Corporation D/B/A Conmed Linvatec MAI Class II 2012-08-22
K121764 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek, Inc. NKB Class II 2012-08-21
K121148 SAMBA SCREW, 9MM DIA., 25MM LONG, SAMBIA SCREW, 9MM DIA., 30MM LONG, SAMBA SCREW 9MM DIA., 35MM LONG, SAMBA SCREW, 9MM D Medical Design, LLC HWC Class II 2012-08-20
K121452 GRIDLOCK PLATING SYSTEM Trilliant Surgical, Ltd. HRS Class II 2012-08-20
K120486 AVS AS PEEK SPACER Stryker Spine ODP Class II 2012-08-20
K121176 STGC Cardinal Spine, LLC MQP Class II 2012-08-17
K120030 TAPERLOC COMPLETE SIZE 4MM AND XR 123 Biomet Manufacturing Corp LPH Class II 2012-08-17
K122145 LANX SPINAL FIXATION SYSTEM Lanx, Inc. NKB Class II 2012-08-17
K121548 SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS) Spine View, Inc. HRX Class II 2012-08-16
K121727 MOVATION KNEE SYSTEM Encore Medical L.P. OIY Class II 2012-08-15
K121615 4CIS VANE SPINE SYSTEM Solco Biomedical Co., Ltd. MNI Class II 2012-08-15
K112548 ALTOMEC ARTHROSCOPE Altomec Endoscopy, Inc. HRX Class II 2012-08-15
K120469 ERISMA-LP Clariance NKB Class II 2012-08-13
K121443 JOURNEY II CR KNEE SYSTEM Smith & Nephew, Inc. JWH Class II 2012-08-13
K120715 ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORT Zimmer GmbH HSB Class II 2012-08-10
K121320 C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE Medyssey Co, Ltd. ODP Class II 2012-08-10
K120553 ESPIN Nlt Spine, Ltd. HRX Class II 2012-08-09
K120714 PICASSO MIS SPINAL FIXATION SYSTEM Accel Spine NKB Class II 2012-08-09
K121221 PROFEMUR Z REVISION HIP STEM Wrightmedicaltechnologyinc LZO Class II 2012-08-09
K121136 RENOIR POSTERIOR CERVIAL FIXATION SYSTEM Accel Spine KWP Class II 2012-08-09
K121172 REFORM PEDICLE SCREW SYSTEM Spinal USA MNI Class II 2012-08-08
K111953 NAUTILUS SPINAL SYSTEM Life Spine NKB Class II 2012-08-07
K121393 SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION Smith & Nephew, Inc. MBH Class II 2012-08-07
K121940 LANX SPINAL FIXATION SYSTEM Lanx, Inc. NKB Class II 2012-08-02
K120838 SYNTHES MATRIX SYSTEM Synthes Spine NKB Class II 2012-07-31
K120467 SPINAL ELEMENTS POSTERIOR CERVICAL/THORACIC SPINAL SYSTEM Spinal Elements, Inc. NKB Class II 2012-07-30
K121544 DYNASTY BIOFOAM SHELL Wrightmedicaltechnologyinc KWA Class III 2012-07-30
K121299 STERISPINEPS PEDICLE SCREW, STERISPINEPS ROD Safe Orthopaedics NKB Class II 2012-07-30
K121308 HIP SYSTEMS Howmedica Osteonics Corp. LPH Class II 2012-07-30
K121879 VEGA KNEE SYSTEM Aesculap Implant Systems JWH Class II 2012-07-27
K121569 MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM Accel Spine ODP Class II 2012-07-27
K121922 BEACON STABILIZATION SYSTEM Globus Medical, Inc. NKB Class II 2012-07-26
K120509 STRYKER ALL SUTURE ANCHORS Stryker MBI Class II 2012-07-26
K121183 COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMS Biomet Corporation PHX Class II 2012-07-26
K120016 PIONEER STERNAL ASSIST IMPLANT SYSTEM Pioneer Surgical Technology, Inc. HRS Class II 2012-07-26
K113285 LDR SPINE USA AVENUE L INTERBODY FUSION Ldr Spine USA, Inc. OVD Class II 2012-07-26
K121982 SOVEREIGN SPINAL SYSTEM Medtronic Sofamor Danek OVD Class II 2012-07-26
K121252 HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM Stryker Corp. KTT Class II 2012-07-25
K120262 HLS UNI EVOLUTION & U-KNEETEC Tornier, Inc. HSX Class II 2012-07-25
K121852 SYNTHES ZERO-P VARIABLE ANGLE (VA) Synthes Spine Co.Lp OVE Class II 2012-07-25
K121835 DOMED TRI-PEG PATELLA, HIGHLY CROSS LINKED DOMED TRI-PEG PATELLA WITH VE Encore Medical L.P. JWH Class II 2012-07-20
K121808 CASIAN, 3.5/4.5 CONNECTORS K2m, Inc. KWP Class II 2012-07-20
K112389 SURGICASE CONNECT, SURGICASE GUIDE Materialise NV PBF Class II 2012-07-20
K121658 ORTHOFIX ACP (ANTERIOR CERVICAL PLATE SYSTEM) Orthofix, Inc. KWQ Class II 2012-07-20
K121416 GMK SPHERE Medacta International JWH Class II 2012-07-20
K120211 SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING Smith & Nephew, Inc. LZO Class II 2012-07-19
K121417 XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM Extremity Medical, LLC HWC Class II 2012-07-18
K121349 IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER Extremity Medical, LLC HWC Class II 2012-07-18
K121115 M.U.S.T PEDICLE SCREW SYSTEM Medacta International KWP Class II 2012-07-18
K121323 MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATE Medicrea International KWQ Class II 2012-07-18
K121671 PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM Zimmer Spine, Inc. NKB Class II 2012-07-18
K120824 3.9MM REELX STT SUTURE ANCHOR SYSTEM Stryker Corp. MBI Class II 2012-07-18
K121777 U2 ACETABULAR CUP, PLASMA SPRAY United Orthopedic Corp. LPH Class II 2012-07-18
K121837 NUVASIVE BRIGADE ANTERIOR PLATE SYSTEM Nuvasive, Inc. KWQ Class II 2012-07-16
K120564 CALYPSO SYSTEM Hogan Lovells US LLP NKB Class II 2012-07-16
K121733 INFILL INTERVERTEBRAL BODY FUSION DEVICE Pinnacle Spine Group, LLC MAX Class II 2012-07-13
K120903 CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE Acumed, LLC HRS Class II 2012-07-13
K112193 ARROW REVERSE SHOULDER SYSTEM Fournitures Hospitalieres Industrie PHX Class II 2012-07-12
K112748 SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM Spinal USA, LLC KWQ Class II 2012-07-11
K120374 SEVIIN REVERSE SHOULDER Ingen Orthopedics, LLC PHX Class II 2012-07-09

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