meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
36
Latest Decision
2015-10-29

Clearances · page 54 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K151456 Small Bone Nail Implant Vilex IN Tennessee, Inc. HSB Class II 2015-10-29
K151718 iFuse Implant System SI-BONE, Inc. OUR Class II 2015-10-29
K143716 DSM Biomedical DPR Cable Dsm Biomedical JDQ Class II 2015-10-29
K152527 Integra DigiFuse Cannulated Intramedullary Fusion System Ascension Orthopedics HWC Class II 2015-10-29
K150523 AVAmax Vertebral Balloon Care Fusion HRX Class II 2015-10-29
K152315 JOURNEY II Uni Tibial Base and Insert Smith & Nephew, Inc. HSX Class II 2015-10-28
K152039 Genesys Spine TiLock2 Spinal System Genesys Spine NKB Class II 2015-10-28
K152338 VERTEX(r) Reconstruction System Medtronic Sofamor Danek USA, Inc. NKG Class II 2015-10-28
K152457 CD HORIZON Spinal System Medtronic Sofamor Danek USA, Inc. NKB Class II 2015-10-27
K151769 Anchorage 2 CP System Stryker GmbH HRS Class II 2015-10-27
K150241 Genesis II XLPE Resurfacing Patellar Components Smith & Nephew, Inc. JWH Class II 2015-10-27
K150780 Acetabular Cup Orientation System Materialise NV PLW Class II 2015-10-27
K152169 Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial Inserts Ortho Development Corporation JWH Class II 2015-10-27
K150474 NuVasive VuePoint II OCT System Nu Vasive, Incorporated NKG Class II 2015-10-21
K152704 iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee Replacement System Conformis, Inc. JWH Class II 2015-10-21
K151938 S4 Cervical Spinal and Occiput Systems Aesculap Implant Systems, LLC NKG Class II 2015-10-21
K152726 JOURNEY II XR Knee System Smith & Nephew, Inc. JWH Class II 2015-10-21
K150855 H-MAX S Femoral Hip System Lima Corporate S.P.A. MEH Class II 2015-10-21
K152156 Opticage Expandable Interbody Fusion Device Interventional Spine, Inc. MAX Class II 2015-10-19
K150918 PASS OCT Spinal System Medicrea International SA NKG Class II 2015-10-16
K151648 Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle Screw System, Valencia MIS Pedicle Screw System Altus Partners, LLC NKB Class II 2015-10-16
K152455 Amendia Cervical Plate System Amendia, Inc. KWQ Class II 2015-10-15
K152710 HammerFiX Device Extremity Medical, LLC HWC Class II 2015-10-15
K151220 Dunamis Interference Screw Dunamis, LLC MBI Class II 2015-10-14
K152621 OSS/Arcos IM Total Femur Rod Biomet, Inc. JDI Class II 2015-10-14
K151785 Px HA PEEK IBF System Innovasis, Inc. MAX Class II 2015-10-14
K150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C(HA) Cervical Intervertebral Body Fusion Devices Meditech Spine, LLC ODP Class II 2015-10-14
K150693 PHIN-FX Cannulated Lag Screw System Ascent Medical, LLC HWC Class II 2015-10-13
K151596 Endoskeleton TCS Interbody Fusion Device Titan Spine, LLC OVE Class II 2015-10-09
K151352 CONCORDE Bullet Spinal System Medos International SARL MAX Class II 2015-10-08
K151921 STERISPINE PS Safe Orthopaedics NKB Class II 2015-10-08
K151584 AttraX Putty Progentix Orthobiology BV MQV Class II 2015-10-08
K151266 Physica CR Knee System Lima Corporate S.P.A. JWH Class II 2015-10-06
K151360 Inion Spinal Graft Containment System Inion OY OJB Class II 2015-10-06
K150209 Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Bioknotless BR Anchor, Lupine BR Anchor, PanaLok Anchor,PanaLok Anchor with Orthocord, PanaLok RC QuickAnchor Plus; PanaLok RC QuickAnchor Plus Dual Suture, PanaLok RC QuickAnchor Plus w/Orthocord; PanaLok RC QuickAnchor Plus Dual Suture w/Orthocord, PanaLok Loop Anchor, Lupine Loop Anchor, PanaLok RC Lop Anchor, BioKnotless Anchor, BioKnotless RC Anchor, RC Loop Anc Depuy Mitek, A Johnson and Johnson Company MAI Class II 2015-10-06
K151603 Arcos One-piece Femoral Revision System Biomet, Inc. LPH Class II 2015-10-06
K151500 Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) Custom Orthopaedic Solutions KWS Class II 2015-10-05
K151747 STERISPINE PS Safe Orthopaedics NKB Class II 2015-10-05
K151408 LOSPA IS Spinal System Corentec Co., Ltd. MAX Class II 2015-10-02
K143518 Valeo Spacer System and Valeo II Interbody Fusion Device System Amedica Corp. MAX Class II 2015-10-02
K151615 TiTHON Staple with OsseoTi Technology Biomet Manufacturing Corp JDR Class II 2015-10-02
K151849 Seneka I Polyscrew Pedicle Fixation System Senecka Spine NKB Class II 2015-09-30
K143245 GPC Intramedullary Nailing Systems Gpc Medical Limited HSB Class II 2015-09-30
K152171 Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4 Orthofix Srl KTT Class II 2015-09-28
K152158 ARIX Ankle System Jeil Medical Corporation KTT Class II 2015-09-28
K151651 NuVasive X-CORE Mini Cervical Expandable VBR System Nu Vasive, Incorporated PLR Class II 2015-09-25
K150829 U2 Total Knee System- Additional Sizes United Orthopedic Corporation JWH Class II 2015-09-25
K150832 U2 Femoral Component, CR, Porous Coated, Additional Sizes United Orthopedic Corporation MBH Class II 2015-09-25
K143479 Bluefin Interbody System Tides Medical MAX Class II 2015-09-25
K152132 X-spine Pedicle Screw System X-Spine Systems, Inc. MNI Class II 2015-09-25
K152193 Renovis Anterior Cervical Plate System Renovis Surgical Technologies, Inc. KWQ Class II 2015-09-25
K150862 DePuy Actis Duofox Hip Prosthesis DePuy Orthopaedics, Inc. MEH Class II 2015-09-25
K150650 neon3 Ulrich GmbH & Co. KG NKG Class II 2015-09-24
K151293 Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis Tornier S.A.S. KWS Class II 2015-09-24
K151592 Gemmed pedicle screw spinal system Suzhou Gemmed Medical Instrument Co., Ltd. MNI Class II 2015-09-24
K152281 Pyrenees Cervical Plate System K2m KWQ Class II 2015-09-24
K152072 CrossRoads Screw System Crossroads Extremity Systems, LLC HWC Class II 2015-09-23
K143685 Hedgehog Cervical Interbody Fusion Device Vertera, Inc. ODP Class II 2015-09-23
K150765 LDR Spine ROI-C Cervical Cage System Ldr Spine USA OVE Class II 2015-09-17
K152098 ODALYS Pedicle Screw System Kisco International MNI Class II 2015-09-17
K152131 Reliance Spinal Screw System Reliance Medical Systems, LLC MNI Class II 2015-09-17
K151727 Everest Spinal System K2m, Inc. NKB Class II 2015-09-17
K143450 Ackermann Intervertebral Body Fusion Device Ackermann Instrumente GmbH ODP Class II 2015-09-16
K152142 RECON system - MPJ-Plates Normed Medizin-Technik GmbH HRS Class II 2015-09-16
K150619 CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System Orthofix, Inc. ODP Class II 2015-09-11
K151472 NuVasive CoRoent Lumbar System Nu Vasive, Incorporated MAX Class II 2015-09-10
K151695 Romeo posterior osteosynthesis system Spineart MNH Class II 2015-09-10
K151322 Amendia Interbody Fusion Devices Amendia, Inc. MAX Class II 2015-09-10
K152302 Xenco Medical Cervical Interbody System (Argus) Xenco Medical, LLC ODP Class II 2015-09-10
K150576 TGM Biolox delta Ceramic Heads Tgm Medical, Inc. LZO Class II 2015-09-09
K151601 SECURE-LOOP Xiros, Ltd. MBI Class II 2015-09-09
K150064 Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15) Orthogem, Ltd. MQV Class II 2015-09-04
K152015 Pyrenees Cervical Plate System K2m, Inc. KWQ Class II 2015-09-04
K151538 NuVasive PEEK Corpectomy Railed System Nu Vasive, Incorporated MQP Class II 2015-09-04
K151733 Xenco Medical Pedicle Screw System Xenco Medical, LLC NKB Class II 2015-09-04
K151442 TOTAL COMPRESSION PLATING (TCP) SYSTEM Wrightmedicaltechnologyinc HRS Class II 2015-09-04
K151270 CrossTIE Intraosseous Fixation System Crossroads Extremity Systems, LLC HWC Class II 2015-09-04
K151160 Arcus Staple System Nextremity Solutions, Inc. JDR Class II 2015-09-04
K150768 JuggerKnot Soft Anchors Biomet Manufacturing Corp MBI Class II 2015-09-04
K151838 PRO-TOE Hammertoe Fixation System Wrightmedicaltechnologyinc HWC Class II 2015-09-04
K151167 NuVasive PEEK Corpectomy System Nu Vasive, Incorporated MQP Class II 2015-09-03
K151902 REDAPT¿ Revision Femoral System Smith & Nephew, Inc. LZO Class II 2015-09-03
K151705 Lotus Posterior Cervical/Thoracic Spinal System Spinal Elements, Inc. NKG Class II 2015-09-03
K151440 Klassic HD Hip System Total Joint Orthopedics, Inc. LPH Class II 2015-09-03
K151885 SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System Depuy Synthes, Inc. NKG Class II 2015-09-03
K143631 Benefix Interspinous Fixation System U&I Corporation PEK Class II 2015-09-03
K152170 Exactech Optetrak Logic Enhanced Assembly Exactech, Inc. JWH Class II 2015-09-03
K150812 Genesys Spine Apache Cervical Interbody Fusion System Genesys Spine ODP Class II 2015-09-03
K141960 Exactech® Novation® Crown Cup® Exactech, Inc. LPH Class II 2015-09-03
K152148 Fortress Pedicular Fixation System Spineology, Inc. NKB Class II 2015-09-02
K152174 Sniper Spine System Spine Wave, Inc. MNI Class II 2015-08-31
K151459 Integra Total Ankle Replacement System Ascension Orthopedics HSN Class II 2015-08-31
K150896 Vitality Spinal Fixation System Zimmer Spine, Inc. NKB Class II 2015-08-31
K151732 Arthrex Fracture Plates Arthrex, Inc. HRS Class II 2015-08-28
K151740 JAZZ System Implanet, S.A. OWI Class II 2015-08-27
K143721 PRCT2 Fx Solutions HRS Class II 2015-08-27
K152071 NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only) Novabone Products, LLC MQV Class II 2015-08-26
K151008 LINK® MEGASYSTEM-C® Waldemar Link GmbH & Co. KG KRO Class II 2015-08-26
K150673 SYNFIX Evolution Secured Spacer System Synthes (USA) Products, LLC OVD Class II 2015-08-21
K151756 STERISPINE LC CAGE Safe Orthopaedics MAX Class II 2015-08-21

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