meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
30
Latest Decision
2013-04-03

Clearances · page 69 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K130194 ACCULIF XL CAGE Coalign Innovations, Inc. MAX Class II 2013-04-03
K123850 IFUSE IMPLANT SYSTEM SI-BONE, Inc. OUR Class II 2013-04-01
K123906 VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEM Medtronic Sofamor Danek USA, Inc. KWP Class II 2013-04-01
K130286 STREAMLINE MIS SPINAL FIXATION SYSTEM Pioneer Surgical Technology, Inc. NKB Class II 2013-04-01
K123997 TRANS1LATERAL INTERBODY FUSION SYSTEM Trans1, Inc. MAX Class II 2013-04-01
K123954 INFINITY TOTAL ANKLE SYSTEM Wrightmedicaltechnologyinc HSN Class II 2013-04-01
K130402 SPIDER SYSTEM KOLIBRI CEMENT NEEDLE Sintea Plustek, LLC NDN Class II 2013-04-01
K123562 FLOWER SMALL AND MEDIUM BONE IMPLANTS Flower Orthopedics Corporation HRS Class II 2013-03-29
K122850 TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES Meditech Advisors, LLC ODP Class II 2013-03-28
K122770 BIOMET RECONSTRUCTIVE WEDGES MODEL 110003660-99, 110003797-831 Biomet Manufacturing Corp HRS Class II 2013-03-28
K123100 INTESS LUMBAR CAGE Kalitec Direct, LLC MAX Class II 2013-03-28
K122175 MENDEC SPINE HV, MENDEC SPINE HV SYSTEM Tecres S.P.A. NDN Class II 2013-03-28
K130176 FIREBIRD SPINAL FIXATION SYSTEM Orthofix NKB Class II 2013-03-28
K123964 AXSOS 3 TI LOCKING PLATE SYSTEM Stryker Trauma AG HRS Class II 2013-03-28
K130625 12MM AND 13MM TIBIAL NAILS Advanced Orthopaedic Solutions, Inc. HSB Class II 2013-03-28
K113871 PRO-DENSE BONE GRAFT SUBSTITUTE Wrightmedicaltechnologyinc MQV Class II 2013-03-25
K123745 SP2 FEMORAL LOCKING NAIL, SP2 TIBIAL LOCKING NAIL Biomecanica Industria E Comerico DE Productos Orto HSB Class II 2013-03-25
K130396 RAMPART O AND RAMPART P Spineology, Inc. MAX Class II 2013-03-25
K122037 ANATOMIC PEEK CERVICAL FUSION SYSTEM CORNERSTONE PSR CERVICAL FUSION SYSTEM PEEK PREVAIL CERVICAL INTERBODY DEVICE CAPST Medtronic Sofamor Danek, Inc. MAX Class II 2013-03-22
K130009 VARIAX 2 COMPRESSION PLATING SYSTEM Stryker Trauma AG HRS Class II 2013-03-22
K123652 SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE Spineology, Inc. MAX Class II 2013-03-22
K123457 BALANCED KNEE SYSTEM HIGH FLEX PS Ortho Development Corp. JWH Class II 2013-03-22
K120354 BETA-TCP GRANULES Skeletal Kinetics, LLC MQV Class II 2013-03-21
K122218 ADVANCE TOTAL KNEE SYSTEM-PATELLA Wrightmedicaltechnologyinc MBH Class II 2013-03-21
K121979 PASS OCT SPINAL SYSTEM Medicrea International KWP Class II 2013-03-21
K122160 VANGUARD XP KNEE SYSTEM Biomet Manufacturing Corp MBH Class II 2013-03-20
K123687 OPTETRAK LOGIC POROUS FEMORAL COMPONENT Exactech, Inc. JWH Class II 2013-03-20
K123403 AXSOS PROXIMAL LATERAL TIBIA LONG PLATES Stryker Trauma AG HRS Class II 2013-03-20
K123832 OIC DISTAL RADIUS PLATING SYSTEM, OIC PROXIMAL HUMERUS PLATING SYSTEM, OIC CLAVICLE PLATING SYSTEM, THE OIC SMALL FRAGME The Orthopaedic Implant Company (Oic) HRS Class II 2013-03-20
K123767 LANX FUSION SYSTEM- SA Lanx, Inc. OVD Class II 2013-03-18
K123890 ACUMED CANNULATED SCREW SYSTEM Acumed, LLC HWC Class II 2013-03-18
K123485 JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOF Biomet Sports Medicine MBI Class II 2013-03-18
K122059 ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORS Smith & Nephew, Inc. MBI Class II 2013-03-18
K122415 X-FIX DYNAMIC EXTERNAL DISTRACTOR Arex USA, LLC HTY Class II 2013-03-15
K123225 BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60 Aap Biomaterials GmbH & Co. KG LOD Class II 2013-03-15
K123782 PARAGON HIP SYSTEM Global Manufacturing Technology LZO Class II 2013-03-14
K123783 ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM AND CAPITOL IMPLANTS Globus Medical, Inc. KWP Class II 2013-03-14
K123948 CHINA NAILS AND ACCESSORIES Smith & Nephew, Inc. JDS Class II 2013-03-14
K130351 NANOTACK SUTURE ANCHOR 1.4MM WITH FLEX INSERTER Pivot Medical, Inc. MBI Class II 2013-03-14
K123862 ZIMMER NEXEL TOTAL ELBOW Zimmer, Inc. JDC Class II 2013-03-12
K122113 MEMORY METAL STAPLES, EASYCLIP Stryker Corp. JDR Class II 2013-03-12
K123939 S4 SPINAL SYSTEM Aesculap Implant Systems, Inc. NKB Class II 2013-03-12
K123702 SILEX SACROILIAC JOINT FUSION SYSTEM X-Spine Systems, Inc. OUR Class II 2013-03-11
K123875 AAP RADIUS SET 2.5 Aap Implantate AG HRS Class II 2013-03-11
K123487 GSO GS1 CANNULATED SCREW SYSTEM Gold Standard Orthopaedics, LLC MNH Class II 2013-03-11
K130128 TRINITY ACETABULAR SYSTEM Corin Medical LZO Class II 2013-03-08
K123350 ECLIPSE SOFT TISSUE FASTENER MedShape, Inc. MBI Class II 2013-03-07
K123081 BONOS R GENTA 1X20 MODEL 01-0228; BONOS R GENTA 2X20 MODEL 01-0229; BONOS R GENTA 1X40 MODEL 01-0217; BONOS R GENTA 2X40 Aap Biomaterials GmbH & Co. KG LOD Class II 2013-03-07
K123373 NAUTILUS SPINAL SYSTEM Life Spine NKB Class II 2013-03-06
K122513 CLEARED UNDER GRAFTON II EDBM Medtronic Sofamor Danek, Inc. MBP Class II 2013-03-06
K120740 COLS® FIXATION SYSTEM Fournitures Hospitalieres Industrie MBI Class II 2013-03-05
K130116 SUPERIOR LATERAL VARIAX CLAVICLE PLATE Stryker Trauma AG HRS Class II 2013-03-05
K123993 SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM Alphatec Spine, Inc. OVD Class II 2013-03-05
K123717 UCENTUM Ulrich GmbH & Co. KG NKB Class II 2013-03-04
K123392 AVENIR MULLER STEM Zimmer GmbH LZO Class II 2013-03-04
K123059 INBONE ( I AND II) TOTAL ANKLE SYSTEMS Wrightmedicaltechnologyinc HSN Class II 2013-03-04
K123602 TM ARDIS INTERBODY SYSTEM INSERTER Zimmer Trabecular Metal Technology MAX Class II 2013-03-01
K123924 DEPUY GRIPTION TF 5.5MM STERILE LOCKING SCREWS Depuy Orthopaedics LZO Class II 2013-03-01
K122872 INTERVERTEBRAL BODY FUSION DEVICE Dio Medical Co., Ltd. ODP Class II 2013-02-28
K122936 ANKLE TRAUMA SYSTEM Orthopro, LLC HRS Class II 2013-02-28
K123501 OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS Biomet, Inc. JDI Class II 2013-02-27
K130061 PICCOLO COMPOSITE PLATE SYSTEM CarboFix Orthopedics , Ltd. HRS Class II 2013-02-27
K130196 SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR Arthrocare Corp. MBI Class II 2013-02-27
K123672 INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW) Inion OY HWC Class II 2013-02-27
K130092 SIMMETRY SACROILIAC JOINT FUSION SYSTEM Zyga Technology, Inc. OUR Class II 2013-02-27
K123656 VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM Medtronic Sofamor Danek USA, Inc. KWP Class II 2013-02-25
K123549 POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM Biomet Spine (Aka Ebi, LLC) NKB Class II 2013-02-25
K130143 PERSONA NATURAL TIBIA BASEPLATES Zimmer, Inc. JWH Class II 2013-02-22
K122185 U-MOTION II ACETABULAR SYSTEM United Orthopedic Corp. LZO Class II 2013-02-22
K122015 DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE Howmedica Osteonics Corp. KRO Class II 2013-02-22
K123459 ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEM Zimmer, Inc. MBH Class II 2013-02-22
K123809 CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. NKB Class II 2013-02-22
K123651 CINCHLOCK KNOTLESS SUTURE ANCHOR Pivot Medical MBI Class II 2013-02-21
K122967 LUCENT Spinal Elements, Inc. MAX Class II 2013-02-21
K123425 TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL Smith & Nephew, Inc. MBI Class II 2013-02-20
K122518 SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA PLIF CAGE TALON TIFA CAGE Bm Korea Co., Ltd. ODP Class II 2013-02-15
K123525 GRIDLOCK PLATING SYSTEM Trilliant Surgical, Ltd. HRS Class II 2013-02-15
K123164 SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM Spinefrontier, Inc. MNH Class II 2013-02-15
K123240 SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT ArthroCare Corporation MBI Class II 2013-02-14
K123623 ILLICO MIS POSTERIOR FIXATION SYSTEM Alphatec Spine, Inc. NKB Class II 2013-02-14
K120038 A200 KNEE SYSTEM Renovis Surgical Technologies, LLC OIY Class II 2013-02-14
K123918 MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATE SYSTEM Zimmer, Inc. HRS Class II 2013-02-14
K123166 TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POSTERIOR STABILIZING (P Howmedica Osteonics Corp. JWH Class II 2013-02-14
K121826 INTEGRA PROXIMAL HUMERAL PLATE SYSTEM Ascension Orthopedics, Inc. HRS Class II 2013-02-13
K123412 RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTS K2m, Inc. OSH Class II 2013-02-13
K123705 TRINITY NON-OCCLUDED TITANIUM PLASMA SPRAYED (TPS) ACETABULAR SHELLS Corin USA LZO Class II 2013-02-12
K121877 GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM ARTICULATING ROD, GIBRALT OCCIPITAL PLATES Exactech, Inc. KWP Class II 2013-02-12
K122411 J-SCOPE SYSTEM Myelotec HRX Class II 2013-02-11
K123688 PROFEMUR TL CLASSIC HIP STEM Wrightmedicaltechnologyinc LZO Class II 2013-02-08
K123232 SPINEOLOGY SPINOUS PROCESS PLATE Spineology, Inc. KWP Class II 2013-02-07
K122822 SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM Spectrum Spine, LLC NQW Class II 2013-02-07
K123521 RELIANCE SPINAL SCREW SYSTEM Reliance Medical Systems, LLC MNI Class II 2013-02-07
K122871 COMPRESSYN STAPLE Dallen Medical, Inc. JDR Class II 2013-02-07
K130057 ESPIN Nlt Spine, Ltd. HRX Class II 2013-02-07
K123969 XIPHOS Difusion Technologies MAX Class II 2013-02-07
K123206 MAXIM SURGICAL X-TREME INTERBODY FUSION SYSTEM Maxim Surgical ODP Class II 2013-02-07
K122805 PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR Parcus Medical, LLC MBI Class II 2013-02-05
K122183 AUGMENT AND SCREW, PSA TYPE United Orthopedic Corp. JWH Class II 2013-02-05
K123434 PROFEMUR Z CLASSIC STEMS Wrightmedicaltechnologyinc LZO Class II 2013-02-05
K123138 PASS LP SPINAL SYSTEM Medicrea International OSH Class II 2013-02-05

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