meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
32
Latest Decision
2012-05-01

Clearances · page 74 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K112986 LATERAL FUSION DEVICE Integra Spine (Integra Lifesciences) MAX Class II 2012-05-01
K113848 R3 XLPE LINERS Smith & Nephew, Inc. MBL Class II 2012-04-27
K120108 APTUS PROXIMAL HUMERUS SYSTEM Medartis AG HRS Class II 2012-04-27
K120517 DEPUY PULSE CERVICAL CAGE SYSTEM Medos International SARL ODP Class II 2012-04-26
K113796 SOLITAIRE-C CERVICAL SPACER SYSTEM Ebi, LLC OVE Class II 2012-04-26
K113760 VARIAX SUPERIOR AND ANTERIOR, LATERAL AND MIDSHAFT CLAVICLE PLATES VARIAX AIMING BLOCKS & JOYSTICK Howmedica Osteonics Corp., Dba Stryker Orthopaedics HRS Class II 2012-04-25
K112611 SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS Sintea Plastek, LLC MNI Class II 2012-04-25
K120645 PRO-TOE(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITION Wrightmedicaltechnologyinc HWC Class II 2012-04-24
K120015 OSTEOMED WRIST PLATING SYSTEM Osteomed LP HRS Class II 2012-04-24
K121004 APEX KIRSCHNER WIRES AND STEINMANN PINS Apex Tools & Orthopedics Co. HTY Class II 2012-04-24
K120589 MILAGRO INTERFERENCE SCREWS Depuy Mitek, A Johnson & Johnson Company MAI Class II 2012-04-24
K120313 NEO CR KNEE SYSTEM Pipeline Orthopedics JWH Class II 2012-04-20
K120942 PARCUS TWIST 4 5MM PEEK SUTURE ANCHOR, PARCUS TWIST 5.5MM PEEK SUTURE ANCHOR & PARCUS TRIPLE TWIST 5.5MM PEEK SUTURE ANC Parcus Medical, LLC MBI Class II 2012-04-20
K120063 VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM L&K BIOMED Co., Ltd. MAX Class II 2012-04-19
K120818 OTIS-C PLUS Science For Biomaterials HRS Class II 2012-04-19
K113789 MODULAR PROXIMALLY FLUTED HIP STEM Smith & Nephew, Inc. MEH Class II 2012-04-19
K120316 ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM Conformis, Inc. JWH Class II 2012-04-19
K120531 VERSAFITCUP CC TRIO-ADDITIONAL LINERS Medacta International LZO Class II 2012-04-18
K112696 TWIN PEAKS LUMBAR CAGE Qualgenix, LLC MAX Class II 2012-04-18
K113593 NEXTGEN ALTIUS OCT SYSTEM Biomet Spine (Aka Ebi, LLC) KWP Class II 2012-04-17
K120165 INTRAOSSEOUS FIXATION SYSTEM Orthohelix Surgical Designs, Inc. HTY Class II 2012-04-17
K113802 ESCALATE LAMINOPLASTY SYSTEM Stryker Spine NQW Class II 2012-04-16
K113352 TRANSCORP SPINAL ACCESS SYSTEM Transcorp, Inc. HRX Class II 2012-04-16
K120291 OP SPINE SYSTEM OrthoPediatrics Corp. OSH Class II 2012-04-16
K120794 ASCEND SHOULDER SYSTEM Tornier, Inc. KWS Class II 2012-04-13
K120092 PLYMOUTH THORACOLUMBAR PLATE SYSTEM Globus Medical, Inc. KWQ Class II 2012-04-13
K120292 CAPLOX II PEDICLE SCREW SYSTEM Captiva Spine, Inc. MNI Class II 2012-04-13
K112438 TITAN MODULAR TOTAL SHOULDER SYSTEM Ascension Orthopedic KWS Class II 2012-04-11
K120390 SOLAFIX TWIST SCREW IMPLANT SYSTEM, SURGICAL INSTRUMENT SET Solana Surgical, LLC HWC Class II 2012-04-10
K120157 MINI MAXLOCK EXTREME PLATING SYSTEM Orthohelix Surgical Designs, Inc. HRS Class II 2012-04-10
K120368 CAPSTONE CONTROL SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. MAX Class II 2012-04-09
K112481 FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT Ascension Orthopedic KXE Class II 2012-04-09
K113170 CERVICAL PLATE Eisertech, LLC KWQ Class II 2012-04-06
K120279 NANOFUSE DBM Nanotherapeutics MQV Class II 2012-04-06
K120570 CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM Choicespine, LP MQP Class II 2012-04-05
K112470 2GC HIP/KNEE MODULAR SPACER Mandell Horwitz Consultants, LLC KWL Class II 2012-04-05
K120656 EVEREST SPINAL SYSTEM K2m, Inc. MNI Class II 2012-04-04
K120667 VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR ANKLE FUSION PLATES, PERI-LOC 3.5MM HINDFOOT Smith & Nephew, Inc. HRS Class II 2012-04-04
K113361 SECURIS SPINAL FIXATION Cumtom Spine NKB Class II 2012-04-03
K120696 TIGER SPINE SYSTEM Corelink, LLC MNI Class II 2012-04-02
K112982 ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL ) Small Bone Innovations, Inc. HSB Class II 2012-04-02
K120802 ORTHOLOC(TM) 3DI LOCKING SCREWS ORTHOLOC(TM) BONE SCREWS Wrightmedicaltechnologyinc HRS Class II 2012-04-02
K113829 ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNE Materialise NV JWH Class II 2012-04-02
K120578 ACCOLADE II HIP STEM Howmedica Osteonics JDI Class II 2012-03-29
K113327 HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM Stryker Corp. KTT Class II 2012-03-29
K112798 LOCKING COMPRESSION PLATE SYSTEM Shanghai Microport Orthopedics Co., Ltd. HRS Class II 2012-03-29
K113058 TIGER SPINE SYSTEM Corelink, LLC NKB Class II 2012-03-29
K120576 ZAVATION IBF SYSTEM Zavation, LLC MAX Class II 2012-03-28
K113695 ELLIPSE PRECICE TRAUMA NAIL SYSTEM Ellipse Technologies, Inc. HSB Class II 2012-03-28
K113324 REXIOUS HOOK FIXATION SYSTEMS Dio Medical Co., Ltd. KWP Class II 2012-03-28
K113369 ZIMMER PERSONA KNEE SYSTEM Zimmer, Inc. JWH Class II 2012-03-27
K120096 MULTIFIX P KNOTLESS FIXATION DEVICE ArthroCare Corporation MBI Class II 2012-03-27
K120101 INDEPENDENCE SPACER Globus Medical, Inc. OVD Class II 2012-03-27
K120270 VENUS SPINAL FIXATION SYSTEM L&K BIOMED Co., Ltd. NKB Class II 2012-03-26
K120538 PALLS M SPINAL SYSTEM Korea Bone Bank Co., Ltd. MNI Class II 2012-03-23
K113733 SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX Neoortho Produtos Ortopedicos S/A HRS Class II 2012-03-23
K120602 APACERAM BONE GRAFT SUBSTITUTE Hoya Corporation MQV Class II 2012-03-23
K120070 SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM Synthes USA HRS Class II 2012-03-21
K113122 PIPELINE CR PRIMARY KNEE SYSTEM Pipeline Orthopedics JWH Class II 2012-03-20
K120540 BIOBOLT Arthrex, Inc. MAI Class II 2012-03-20
K103623 NEWDEAL INTERPHALANGEAL IMPLANT Newdeal Sas HTY Class II 2012-03-20
K112682 METHA HIP SYSTEM Aesculap Implant Systems, LLC LZO Class II 2012-03-19
K120557 SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35 Biomet Spine & Bone Healing Technologies OVD Class II 2012-03-19
K120031 CHESAPEAKE SPINAL SYSTEM K2m, Inc. OVD Class II 2012-03-16
K113320 NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA COATED PRESS-FIT, SZ 8-12 Exactech, Inc. MEH Class II 2012-03-16
K113791 B-GENIN, R-GENIN Berkeley Advanced Biomaterials, Inc. MQV Class II 2012-03-15
K113387 CITIEFFE TITANIUM NAILING SYSTEM Citieffe HSB Class II 2012-03-15
K120074 FOUNDATION SPINAL SYSTEM The Skeletal Design Partnership , Ltd. NKB Class II 2012-03-14
K113756 HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PA Encore Medical L.P. OIY Class II 2012-03-14
K111820 SYNSTER CERVICAL CAGE, ALIF CAGE, PLIF CAGE, PTLIF CAGE, TLIF CAGE Bm Korea Co., Ltd. ODP Class II 2012-03-14
K112561 NUVASIVE COROENT NO-PROFILE SYSTEM Nuvasive, Inc. OVD Class II 2012-03-13
K113157 AILERON INTERSPINOUS FIXATION SYSTEM Life Spine MNI Class II 2012-03-13
K112144 AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESIS Tornier PHX Class II 2012-03-13
K112648 ASFORA BULLET CAGE Medical Designs, LLC MAX Class II 2012-03-13
K110662 ADAPTIVE WEDGE Adaptive Specialty, LLC HRS Class II 2012-03-12
K112663 ENHATCH ORTHOPAEDICS PATIENT/TECHNIQUE-SPECIFIC HUMERAL Enhatch Orthopaedics, LLC HRS Class II 2012-03-12
K113540 RELIANCE LUMBAR IBF SYSTEM Reliance Medical Systems, LLC MAX Class II 2012-03-12
K112757 PIONEER POSTERIOR CERVICO THORACIC SYSTEM Pioneer Surgical Technology, Inc. KWP Class II 2012-03-12
K111663 TRAUMA INTERNAL FIXATION SYSTEMS DePuy Orthopaedics, Inc. HRS Class II 2012-03-12
K112802 PIPELINE TOTAL HIP SYSTEM Pipeline Orthopedics OQG Class II 2012-03-09
K113413 ASCEND SHOULDER SYSTEM Tornier, Inc. KWS Class II 2012-03-09
K120399 LANX SPINAL FIXATION SYSTEM Lanx, LLC NKB Class II 2012-03-09
K120044 ARTHREX UNIVERSII XL GLENOID-PEGGED, ARTHREX UNIVERS II XL GLENOID-KEELED Arthrex, Inc. KWS Class II 2012-03-08
K120434 POWER ADAPTOR INSTRUMENT ACCESSORY Stryker Corp. NKB Class II 2012-03-08
K120355 LEUCADIA 4.5 MM PEDICLE SCREW SYSTEM Phygen, LLC NKB Class II 2012-03-07
K113274 FOOTPRINT ULTRA PK SUTURE ANCHOR Smith & Nephew, Inc. MBI Class II 2012-03-06
K113478 PLIF CAGE Eisertech, LLC MAX Class II 2012-03-05
K111792 MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI Signus Medizintechnik GmbH MAX Class II 2012-03-05
K113297 KNOTILUS ANCHOR SYSTEM T.A.G. Medical Products Corporation, Ltd. MBI Class II 2012-03-02
K120078 HEALIX ADVANCE BR ANCHOR Depuy Mitek Inc., Johnson and Johnson Company MAI Class II 2012-02-29
K113364 2.7MM LCP ULNA OSTEOTOMY SYSTEM Synthes (USA) Products, LLC HRS Class II 2012-02-29
K120293 SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DRIVE Spineology, Inc. MAX Class II 2012-02-29
K113828 DYNANAIL ANKLE ARTHRODESIS NAIL MedShape, Inc. HSB Class II 2012-02-29
K113550 VANGUARD COMPLETE KNEE SYSTEM Biomet Manufacturing Corp JWH Class II 2012-02-29
K112891 APEX REVISION KNEE SYSTEMS Omni Life Science, Inc. JWH Class II 2012-02-29
K113346 NEON SYSTEM Ulrich GmbH & Co. KG KWP Class II 2012-02-28
K120024 MECTALIF TRANSFORAMINAL Medacta International S.A. MAX Class II 2012-02-28
K113482 JOURNEY II DEEP DISHED ARTICULAR INSERTS Smith & Nephew, Inc. JWH Class II 2012-02-27
K113254 SMR MODULAR GLENOID-METAL-BACK SMR MODULAR GLENOID-LINER SMR MODULAR GLENOID-BONE SCREWS Lima Corporate S.P.A. PHX Class II 2012-02-24
K120241 LINEAR HIP STEM, SIZE 5 Encore Medical L.P. LPH Class II 2012-02-24

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