meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
31
Latest Decision
2011-12-20

Clearances · page 76 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K113534 HEALIX KNOTLESS ANCHOR Depuy Mitek, A Johnson & Johnson Company MAI Class II 2011-12-20
K112990 ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE Arthrex, Inc. HTY Class II 2011-12-19
K112885 ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY Zimmer, Inc. HWC Class II 2011-12-19
K110895 ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS Ortho Solutions Limited HWC Class II 2011-12-19
K112862 MECTA-C Medacta International ODP Class II 2011-12-19
K112926 AXSOS LOCKING PLATE SYSTEM Stryker Corp. HRS Class II 2011-12-19
K113434 LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) Lanx, Inc. NKB Class II 2011-12-19
K113121 COMPREHENSIVE REVERSE SHOULDER Biomet Manufacturing, Inc. PHX Class II 2011-12-16
K112819 RECONSTRUCTION LOCKING PLATE AND 3.5MM LOCKING SCREW Xiamen Double Engline Medical Material Co., Ltd. HRS Class II 2011-12-16
K110360 PROPHECY INBONE PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES Wrightmedicaltechnologyinc HSN Class II 2011-12-16
K113270 INSTINCT JAVA SYSTEM Zimmer Spine NKB Class II 2011-12-16
K112388 LANX CERVICAL SA Lanx, Inc. OVE Class II 2011-12-16
K112040 ARTHREX BIOCOMPOSITE TRANSFIX Arthrex, Inc. MAI Class II 2011-12-15
K111746 COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS) Biomet, Inc. KWT Class II 2011-12-15
K113299 ROG SUTURE ANCHOR Rog Sports Medicine, Inc. MBI Class II 2011-12-15
K112876 CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK SP(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5 Cayenne Medical, Inc. MBI Class II 2011-12-15
K113107 MSA HIP SYSTEM Global Manufacturing Technology MEH Class II 2011-12-15
K112560 APTUS(R) DISTAL HUMERUS SYSTEM Medartis AG HRS Class II 2011-12-15
K110633 LANCER PEDICLE SCREW SYSTEM Spinal Solutions, LLC MNH Class II 2011-12-15
K112218 ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS DePuy Orthopaedics, Inc. KTT Class II 2011-12-15
K112780 CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM Conformis, Inc. JWH Class II 2011-12-15
K112316 4-WEB ALIF SPINAL TRUSS SYSTEM (STS) 4-Web, Inc. MAX Class II 2011-12-14
K110604 VBB SYSTEM Synthes NDN Class II 2011-12-13
K112857 INTERFACE BONE VOID FILLER Biostructures, LLC MQV Class II 2011-12-13
K112672 HEADLESS COMPRESSION SCREW Skeletal Dynamics, LLC HWC Class II 2011-12-13
K113348 COUGAR SYSTEM Johnson & Johnson MAX Class II 2011-12-13
K111418 STAXX(R) XD SYSTEM Spine Wave, Inc. MQP Class II 2011-12-13
K112459 SYNTHES ZERO-P Synthes Spine Co.Lp OVE Class II 2011-12-12
K112675 ARROW-LOK DIGITAL SYSTEM Arrowhead Medical Device Technologies, LLC HTY Class II 2011-12-12
K111995 XINGTM SPINE SYSTEM Implanova Co., Ltd. MNH Class II 2011-12-12
K112983 SPACER-S Tecres S.P.A. HSD Class II 2011-12-12
K113465 ACCULIF TL CAGE Coalign Innovations, Inc. MAX Class II 2011-12-12
K112658 OSTEOSPRING FOOTJACK SUBTALAR IMPLANT SYSTEM Osteospring Medical, Inc. HWC Class II 2011-12-12
K113339 ORTHOLOC 3DSI LOCKING SCREWS Wrightmedicaltechnologyinc HRS Class II 2011-12-12
K112028 SI-LOK SACROILIAC JOINT FIXATION SYSTEM Globus Medical, Inc. HWC Class II 2011-12-09
K113084 RENOVIS CANNULATED SCREW SYSTEM Renovis Surgical Technologies, LLC HWC Class II 2011-12-09
K113303 OSLEOBRIDGE IDSF SPACER CONECTOR Merete Medical GmbH HSB Class II 2011-12-09
K111132 GENESYS SPINE ANTERIOR CERVICAL PLATE SYSTEM Genesys Spine KWQ Class II 2011-12-09
K113325 EVOLUTION MP ADAPTIVE CS INSERT Wrightmedicaltechnologyinc JWH Class II 2011-12-09
K112533 ZAVATION CERVICAL PLATE SYSTEM Zavation, LLC KWQ Class II 2011-12-08
K093477 SHIELD KYPHOPLASTY SYSTEM Soteira, Inc. NDN Class II 2011-12-08
K113309 EXACTECH EQUINOXE CAGE GLENOIDS Exactech, Inc. KWS Class II 2011-12-08
K111123 VARILIFT CERVICAL INTERBODY FUSION SYSTEM Wenzel Spine ODP Class II 2011-12-08
K112991 MODIFIED ROG SUTURE ANCHOR Rog Sports Medicine, Inc. MBI Class II 2011-12-08
K110046 ATHENA PEDICLE SCREW SYSTEM Royal Oak Medical Devices NKB Class II 2011-12-07
K110700 ASCENSION ATLAS HUMERAL PLATING SYSTEM Ascension Orthopedics, Inc. HRS Class II 2011-12-06
K111834 DISCO SUBTALAR IMPLANT Trilliant Surgical, Ltd. HWC Class II 2011-12-06
K111667 SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS Synthes (Usa) JDS Class II 2011-12-05
K112592 AXLE PEEK INTERSPINOUS FUSION SYSTEM X-Spine Systems, Inc. KWP Class II 2011-12-05
K112583 SYNTHES CORTICAL SCREWS Synthes (USA) Products, LLC HWC Class II 2011-12-05
K112779 APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM) Omnlife Science LPH Class II 2011-12-02
K112095 ACCULIF TL-PEEK IBF CAGE Coalign Innovations, Inc. MAX Class II 2011-12-01
K112296 LATERAL BUTTON T.A.G. Medical Products Corporation, Ltd. MBI Class II 2011-12-01
K112361 ALAMO C Alliance Partners, LLC ODP Class II 2011-11-30
K111272 RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEM Rhausler, Inc. OVE Class II 2011-11-29
K111908 BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM Biomet Microfixation, Inc. HWC Class II 2011-11-29
K111891 SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS Synthes (USA) Products, LLC HSB Class II 2011-11-28
K111119 TRABECULAR METAL (TM) FUSION DEVICE Zimmer Spine, Inc. ODP Class II 2011-11-23
K112150 PROFEMUR GLADIATOR HA HIP STEM Wrightmedicaltechnologyinc KWA Class III 2011-11-23
K111944 NB3D BONE VOID FILLER Pioneer Surgical Technology, Inc. MQV Class II 2011-11-22
K111690 DEVINE SPINAL SYSTEM Changzhou Orthmed Medical Instrument Co., Ltd. MNH Class II 2011-11-22
K112484 ZAVATION SPINAL SYSTEM Zavation, LLC MNI Class II 2011-11-22
K113174 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. NKB Class II 2011-11-21
K112724 DEPUY PULSE ANTERIOR CERICAL PLATE SYSTEM Medos International SARL KWQ Class II 2011-11-21
K112405 CLYDESDALES SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. MAX Class II 2011-11-21
K112493 PASS LP SPINAL SYSTEM Medicrea International MNI Class II 2011-11-21
K112551 S4 SPINAL SYSTEM Aesculap Implant System, Inc. NKB Class II 2011-11-21
K111593 GUARDIAN INFLATABLE BONE EXPANDER SYSTEM Bm Korea Co., Ltd. NDN Class II 2011-11-18
K111358 SYNTHES USS Synthes Spine NKB Class II 2011-11-18
K111983 VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX Zimmer Trabecular Metal Technology ODP Class II 2011-11-18
K112085 SYNTHES LCP PEDIATRIC PLATE SYSTEMS Synthes (USA) Products, LLC HRS Class II 2011-11-17
K112197 MEMOMETAL INTRA-MEDULLARY BONE FASTENER Memometal Technologies HTY Class II 2011-11-17
K112069 RSP GLENOID BASEPLATE POROUS COATED Encore Medical L.P. PHX Class II 2011-11-15
K112453 STERISPINEPS PEDICLE SCREW Safe Orthopaedics NKB Class II 2011-11-15
K112444 ANATOMIC PEEK CERVICAL FUSION SYSTEM Medtronic Sofamor Danck USA, Inc. ODP Class II 2011-11-15
K112406 PERI-LOC PROXIMAL FEMUR LOCKING BONE PLATES Smith & Nephew, Inc. HRS Class II 2011-11-14
K102413 FUZE: INTRAMEDULLARY INTERNAL FIXATION NAIL Vilex, Inc. HSB Class II 2011-11-14
K112111 ACU-SINCH REPAIR SYSTEM AND ACUMED SUTURE ANCHOR Acumed, LLC HTN Class II 2011-11-14
K113019 PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER Wrightmedicaltechnologyinc KWA Class III 2011-11-10
K111716 KNOTLESS SUTURE FIXATION SYSTEM Core Essence Orthopaedics MBI Class II 2011-11-10
K110442 NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM Nanovis, LLC ODP Class II 2011-11-09
K111097 HUMELOCK CEMENTED SHOULDER PROSTHESIS Fx Solutions HSD Class II 2011-11-09
K110562 TELAMON PEEK SPINAL SYSTEM Medtronic Sofamor Danek USA MAX Class II 2011-11-09
K112036 CALIX PC SPINAL IMPLANT SYSTEM X-Spine Systems, Inc. ODP Class II 2011-11-08
K112359 PROW FUSION Nlt Spine, Ltd. MAX Class II 2011-11-08
K112068 SYNTHES ZERO-P VARIABLE ANGLE (VA) Synthes Spine Co.Lp OVE Class II 2011-11-07
K112278 ASCENSION NUGRIP CMC IMPLANT Ascension Orthopedic KYI Class II 2011-11-04
K112285 MILESTONE KNEE SYSTEM, FEMORAL COMPONENT, POSTERIOR STABLIZED, UNOCATED / RLP, UNCOATED; TIBIAL INSERT / BASEPLATE... Tgm Medical, Inc. JWH Class II 2011-11-04
K112509 TRIMED CLAVICLE FIXATION SYSTEM TriMed, Inc. HRS Class II 2011-11-04
K111902 AEQUALIS SHOULDER SYSTEM Tornier KWS Class II 2011-11-03
K110426 DYNA-EXTOR II Bk Meditech, Co., Ltd. KTT Class II 2011-11-02
K112931 LEUCADIA(TM) MIS PEDICLE SCREW SYSTEM Phygen, LLC NKB Class II 2011-11-02
K112965 NANO SUTURE ANCHOR Linvatec Corporation D/B/A Conmed Linvatec MBI Class II 2011-11-02
K112345 DISTAL VOLAR RADIUS PLATING SYSTEMS Medos International SARL LXT Class II 2011-10-31
K103251 DUOCENTRIC REVERSED Aston Medical PHX Class II 2011-10-28
K111796 INVIZIA ANTERIOR CERVICAL PLATE SYSTEM Zimmer Spine, Inc. KWQ Class II 2011-10-27
K110655 MAHE PERFECT SPINE- PEDICLE SCREW SYSTEM Mahe Medical GmbH NKB Class II 2011-10-27
K110551 EXPEDIUM SPINE SYSTEM Johnson & Johnson NKB Class II 2011-10-26
K112689 SYNTHES STERNAL FIXATION SYSTEM Synthes, Inc. HRS Class II 2011-10-26
K112174 NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM Zimmer, Inc. HRS Class II 2011-10-26

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