meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
34
Latest Decision
2013-10-17

Clearances · page 66 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K131167 UNIVATION Aesculap Implant Systems, LLC HRY Class II 2013-10-17
K131405 IFUSE IMPLANT SYSTEM SI-BONE, Inc. OUR Class II 2013-10-16
K132461 A.I.M. SUTURE ANCHOR Anchor Innovation Medical, Inc. MBI Class II 2013-10-16
K131022 OVATION 10/12 HIP STEM Ortho Development Corp. LPH Class II 2013-10-16
K130254 PROW FUSION Nlt Spine, Ltd. MAX Class II 2013-10-16
K131640 SMOOTH OR THREADED METALLIC BONE FASTENER Biomedical Ent., Inc. HTY Class II 2013-10-16
K131231 AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS Tornier S.A.S. PHX Class II 2013-10-16
K131677 PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM Ellipse Technologies, Inc. HSB Class II 2013-10-11
K131337 BALANCED KNEE SYSTEM HIGH FLEX VITAMIN E PS TIBIAL INSERT AND PATELLA Ortho Development Corp. JWH Class II 2013-10-11
K132161 OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTS Exactech, Inc. JWH Class II 2013-10-11
K131636 POLARUS CONNECT Acumed, LLC LXT Class II 2013-10-10
K131684 BIOLOX(R) DELTA CERAMIC HEADS Biomet, Inc. LZO Class II 2013-10-10
K132412 INERTIA MIS PEDICLE SCREW SYSTEM Nexxt Spine, LLC MNI Class II 2013-10-10
K131178 IDYS LIF CAGES Clariance MAX Class II 2013-10-10
K131365 T2 TIBIAL NAILING SYSTEM Stryker Trauma AG HSB Class II 2013-10-10
K130728 POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA Smith & Nephew, Inc. LZO Class II 2013-10-10
K132303 IMPLANET SPINE SYSTEM Implanet, S.A. OSH Class II 2013-10-10
K130390 COMPREHENSIVE CONVERTIBLE GLENOID Biomet Manufacturing, Inc. PHX Class II 2013-10-09
K132704 DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW Biomet LXT Class II 2013-10-09
K131981 CEZANNE II INTERBODY FUSION SYSTEM Accel Spine MAX Class II 2013-10-09
K132589 ANTERIOR LUMBAR PLATE SYSTEM (PRESIDIO) Life Spine, Inc. KWQ Class II 2013-10-08
K131472 APEX KNEE MODULAR TIBIA SYSTEM Omni Life Science, Inc. JWH Class II 2013-10-08
K131186 SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM Synthes (USA) Products, LLC HRS Class II 2013-10-08
K131353 COMPREHENSIVE REVERSE SHOULDER - TITANIUM GLENOSPHERE Biomet Manufacturing Corp PHX Class II 2013-10-08
K132471 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. NKB Class II 2013-10-08
K131769 CINCHLOCK KNOTLESS SUTURE ANCHOR, NANOTACK SUTURE ANCHOR 1.4MM Pivot Medical, Inc. MBI Class II 2013-10-07
K132719 STAXX IBL SYSTEM Spine Wave, Inc. MAX Class II 2013-10-04
K131820 AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G, AVAMAX VERTEBRAL BALLOON SYSTEM, 11G Care Fusion HRX Class II 2013-10-04
K131673 MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT Medtronic Sofamor Danek USA, Inc. MQV Class II 2013-10-03
K132642 LOCKING PLATE SYSTEM Beijing Libeier Bio-Engineering Institute Co., Ltd. HRS Class II 2013-10-03
K132575 PASS LP SPINAL SYSTEM Medicrea International OSH Class II 2013-10-03
K131368 NEO KNEE SYSTEM Pipeline Orthopedics JWH Class II 2013-10-03
K132554 AAP LOQTEQ PROXIMAL MEDIAL TIBIA PLATE 3.5 Aap Implantate AG HRS Class II 2013-10-03
K132361 EVEREST SPINAL SYSTEM K2m, Inc. MNI Class II 2013-10-03
K131824 AVAFLEX VERTEBRAL BALLOON SYSTEM Care Fusion HRX Class II 2013-10-03
K132774 PICCOLO COMPOSITE NAILING SYSTEM CarboFix Orthopedics , Ltd. HSB Class II 2013-10-03
K132760 NAUTILUS SPINAL SYSTEM Life Spine, Inc. NKB Class II 2013-10-03
K131458 MPACT DM LINER CONVERTER Medacta International LZO Class II 2013-10-01
K131845 ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC Acumed, LLC KWI Class II 2013-09-30
K130573 TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIF Tyber Medical, LLC ODP Class II 2013-09-30
K131647 TRINITY ACETABULAR SYSTEM Corin USA LZO Class II 2013-09-27
K131559 MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDES Materialise NV KWS Class II 2013-09-27
K131633 ARTHREX UNIVERS APEX Arthrex, Inc. KWS Class II 2013-09-27
K132700 PERIMETER INTERBODY FUSION DEVICE Medtronic Sofamor Danek, Inc. MAX Class II 2013-09-26
K132287 JAZZ SYSTEM Hogan Lovells US LLP OWI Class II 2013-09-25
K130510 ARTHREX COMPRESSION PLATES Arthrex, Inc. HRS Class II 2013-09-25
K131429 RELIANCE CERVICAL IBF SYSTEM Reliance Medical Systems, LLC ODP Class II 2013-09-23
K131888 T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE Medtronic Sofamor Danek, Inc. MQP Class II 2013-09-23
K132046 PIPELINE KNEE SYSTEM Pipeline Orthopedics JWH Class II 2013-09-23
K130365 X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER Encore Medical L.P. OQG Class II 2013-09-23
K130177 ANATOMIC PEEK CERVICAL FUSION SYSTEM Medtronic Sofamor Danek USA, Inc. ODP Class II 2013-09-23
K131723 COROENT SINGLE TAB SYSTEM Nuvasive, Inc. OVD Class II 2013-09-20
K132632 TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES Tornier, Inc. MBI Class II 2013-09-19
K132644 LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BU Corentec Co., Ltd. MNI Class II 2013-09-19
K132479 OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00 Interventional Spine, Inc. MAX Class II 2013-09-19
K130810 ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEM Zimmer, Inc. HWC Class II 2013-09-19
K132513 Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM AND 2.8MM /BONE PUNCH,2.8MM AND KNOT PUSHER ArthroCare Corporation MBI Class II 2013-09-19
K132626 PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION) Pipeline Biotechnology LPH Class II 2013-09-19
K131354 RENOVIS BIPOLAR HIP SYSTEM Renovis Surgical Technologies, LLC KWY Class II 2013-09-19
K131122 S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM Renovis Surgical Technologies, LLC OVD Class II 2013-09-18
K132590 5.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, 6.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, INSERTION GUIDE WITH OBTURATOR, TA ArthroCare Corporation MBI Class II 2013-09-17
K130595 ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL AND STAINLESS STEEL TIBIAL NAIL Zimmer, Inc. HSB Class II 2013-09-17
K132591 MAXLOCK EXTREME SYSTEM Orthohelix Surgical Designs, Inc. HRS Class II 2013-09-17
K123991 DEPUY CORAIL AMT HIP PROSTHESIS Depuy France S.A.S. KWY Class II 2013-09-16
K132053 RAMPART-O, RAMPART-T Spineology, Inc. MAX Class II 2013-09-16
K131398 NOVOKNEE TOTAL KNEE SYSTEM Novosource, Inc. JWH Class II 2013-09-16
K131409 CAS PSI KNEE SYSTEM Orthosoft, Inc. JWH Class II 2013-09-13
K130641 LOGIC STAND-ALONE INTERVERTEBRAL BODY FUSION DEVICE Binder Biomedical, Inc. OVD Class II 2013-09-13
K130703 VIVORTE BVF Vivorte, Inc. MBP Class II 2013-09-12
K131802 EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM Depuy Spine, A Johnson & Johnson Company OSH Class II 2013-09-12
K132505 ACCULIF TL AND PL CAGE Coalign Innovations, Inc. MAX Class II 2013-09-12
K132005 RETROGRADE FEMORAL NAIL Advanced Orthopaedic Solutions, Inc. HSB Class II 2013-09-10
K131250 TIGER SPINE SYSTEM Corelink, LLC NKB Class II 2013-09-10
K132239 COMPREHENSIVE REVERSE SHOULDER SCREWS Biomet Manufacturing Corp PHX Class II 2013-09-06
K132324 SKYLINE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE 2 ANTERIOR CERVICAL PLATE SYST Medos International SARL KWQ Class II 2013-09-06
K131764 ACUMED WRIST SPANNING PLATE Acumed, LLC HRS Class II 2013-09-05
K131311 ARIX FOOT SYSTEM Jeil Medical Corporation HRS Class II 2013-09-05
K131980 SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM Zimmer Spine, Inc. NKB Class II 2013-09-04
K121924 INTEGRA INTERSPINOUS PROCESS SYSTEM Seaspine, Inc. PEK Class II 2013-09-04
K131615 POLARIS SPINAL SYSTEM Biomet Spine (Aka Ebi, LLC) OSH Class II 2013-09-04
K132366 SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS Accel Spine KWQ Class II 2013-09-03
K132455 U-MOTION II PS+ CUP United Orthopedic Corp. LZO Class II 2013-09-03
K123907 PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS, Biomet Manufacturing Corp KRR Class II 2013-09-03
K131242 ARDIS INTERBODY SYSTEM Zimmer Spine, Inc. MAX Class II 2013-09-03
K131296 VARILIFT-L INTERBODY FUSION DEVICE Wenzel Spine, Inc. MAX Class II 2013-09-03
K131540 INTERFUSE L INTERVERTEBRAL BODY FUSION DEVICE Vertebral Technologies, Inc. MAX Class II 2013-09-03
K132207 UTF STEM-REDUCED, ADDITIONAL SIZES United Orthopedic Corporation LPH Class II 2013-08-30
K131784 RANGE SPINAL SYSTEM K2m, Inc. OSH Class II 2013-08-30
K130610 SIRIUS FEMORAL STEM Biomet, Inc. JDI Class II 2013-08-30
K132012 TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM, TRINICA(R) SELECT ANTERIOR CERVICAL PLATE SYSTEM Zimmer Spine, Inc. KWQ Class II 2013-08-29
K130868 NUVASIVE DECADE LATERAL PLATE SYSTEM Nuvasive, Inc. KWQ Class II 2013-08-29
K131635 ROTATION MEDICAL BONE STAPLE (RMB STAPLE) Rotation Medical, Inc. MBI Class II 2013-08-29
K131200 ASPIRON ACP SYSTEM U&I Corporation KWQ Class II 2013-08-29
K131277 SEVIIN FRACTURE SHOULDER Ingen Orthopedics, LLC KWS Class II 2013-08-28
K131471 SELF-COMPRESSIVE SCREW Neosteo HWC Class II 2013-08-28
K130461 STALIF X Centinel Spine, Inc. OVD Class II 2013-08-28
K130716 BIORETEC ACTIVASCREW INTERFERENCE Bioretec, Ltd. MAI Class II 2013-08-28
K131061 RESTORE BUNION CORRECTION SYSTEM Nextremity Solutions JDR Class II 2013-08-28
K131082 INTERFORM INTERBODY CAGE SYSTEM Next Orthosurgical MAX Class II 2013-08-26
K130635 SEVIIN SURFACE REPLACEMENT SHOULDER Ingen Orthopedics, LLC HSD Class II 2013-08-26

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