meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
30
Latest Decision
2016-01-13

Clearances · page 53 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K152627 IFS Fixation Scaffold System Metric Medical Devices, Inc. HTY Class II 2016-01-13
K152589 Bio2 CLM BG Bioactive Scaffold Bio2 Technologies, Inc. MQV Class II 2016-01-12
K153217 ConforMIS iTotal Posterior Stabilized Knee Replacement System Conformis, Inc. JWH Class II 2016-01-07
K153531 Treace Medical Concepts (TMC) Plating System Treace Medical Concepts, Inc. HRS Class II 2016-01-07
K153336 VuePoint OCT System Nu Vasive, Incorporated NKG Class II 2016-01-07
K153233 Galaxy UNYCO System Orthofix Srl KTT Class II 2016-01-06
K152604 KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set Medtronic Sofamor Danek USA, Incorporated PML Class II 2016-01-06
K151310 Amendia Interbody Fusion Devices Amendia, Inc. MAX Class II 2016-01-06
K153536 Piccolo Composite® Nailing System CarboFix Orthopedics , Ltd. HSB Class II 2016-01-06
K153208 Internal Joint Stabilizer - Elbow Skeletal Dynamics, LLC OZI Class II 2015-12-31
K152968 Arsenal Spinal Fixation System Alphatec Spine, Inc. NKB Class II 2015-12-30
K151876 Bio2 Fusion Implant System Bio2 Technologies, Inc. HTY Class II 2015-12-30
K153463 CD HORIZON Spinal System, IPC POWEREASE System Medtronic Sofamor Danek USA, Inc. NKB Class II 2015-12-30
K151907 Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables Zimmer, Inc. KTT Class II 2015-12-30
K151762 PediatrOS RigidTack/FlexTack Merete Medical GmbH JDR Class II 2015-12-28
K153154 Asnis JFX System Stryker Trauma AG HWC Class II 2015-12-28
K152047 INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid Ascension Orthopedics KWS Class II 2015-12-23
K152370 PRECICE Trauma Nail System Ellipse Technologies, Incorporated HSB Class II 2015-12-22
K152460 Rectangular Corpectomy Cage Amendia, Inc. MQP Class II 2015-12-22
K152755 FastFrame External Fixation System-Ankle Spanning Zimmer, Inc. KTT Class II 2015-12-21
K153378 Monster BITE Screw System Paragon 28 HWC Class II 2015-12-21
K153437 Apex Revision Knee System Omnilife Science JWH Class II 2015-12-21
K152548 AXI+LINE Proximal Bunion Correction System Nextremity Solutions, Inc. HRS Class II 2015-12-21
K152145 OsteoMed ExtremiLOCK Wrist Plating System Osteomed HRS Class II 2015-12-21
K151481 Sahara Stabilization System K2m, Inc. OVD Class II 2015-12-21
K152515 TOMCAT Cervical Spinal System Choicespine, LP OVE Class II 2015-12-18
K152532 AERO -C Cervical Cage System Stryker Spine ODP Class II 2015-12-18
K151062 WASTON Metallic Intramedullary Nail System Changzhou Waston Medical Appliance Co., Ltd. HSB Class II 2015-12-17
K153310 Klassic Knee System Total Joint Orthopedics, Inc. JWH Class II 2015-12-17
K152267 Remedy® Shoulder Spacer Osteoremedies, LLC KWS Class II 2015-12-15
K152651 AccuLIF TL and PL Cage Stryker Corporation MAX Class II 2015-12-15
K151496 Latitude-C Cervical Interbody Spacer System Degen Medical ODP Class II 2015-12-15
K150408 V-STEADY, V-FAST G21, S.R.L. LOD Class II 2015-12-14
K153122 Endoskeleton(r) TCS System Titan Spine, LLC OVE Class II 2015-12-14
K150769 Cardinal Health Trochanteric IM Nail System Cardinalhealth HSB Class II 2015-12-14
K151900 VariLift-L Interbody Fusion Device Wenzel Spine, Inc. MAX Class II 2015-12-11
K153313 SpeedLock Knotless Fixation System ArthroCare Corporation MBI Class II 2015-12-11
K152306 MotoBand¿ CP Implant System Crossroads Extremity Systems, LLC HRS Class II 2015-12-11
K143013 Spinal Inner Fixation System Changzhou Dingjian Medical Appliance Co., Ltd. MNH Class II 2015-12-11
K152987 Xenco Medical Cervical Interbody System, Xenco Medical Lumbar Interbody System Xenco Medical, LLC ODP Class II 2015-12-11
K152974 ORTHOLOC® 3Di Foot Plating Reconstruction System Wrightmedicaltechnologyinc HRS Class II 2015-12-11
K143222 FIREFLY Pedicle Screw Navigation Guide Mighty Oak Medical, Inc. MNI Class II 2015-12-11
K152355 Twin Peaks Lumbar Interbody Fusion System Spineway MAX Class II 2015-12-10
K152732 AOS Small Fragment Plating System Avanced Orthopaedic Solutions, Inc. (Aos) HRS Class II 2015-12-10
K151934 ROI-C Titanium-Coated Implant System Ldr Spine USA OVE Class II 2015-12-07
K152484 FastFrame External Fixation System - Distal Radius Zimmer, Inc. KTT Class II 2015-12-04
K152632 XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory Stryker Corporation NKB Class II 2015-12-02
K152566 PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor, HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor), Bioraptor Curved 2.3 PK Suture Anchors Smith & Nephew, Inc. MBI Class II 2015-12-02
K152239 Zero-P Natural Plate System Synthes (Usa), LLC KWQ Class II 2015-12-02
K150640 RX-FIX Mini Rail External Fixator Wrightmedicaltechnologyinc KTT Class II 2015-12-01
K152943 NuVasive Foundation-LL System Nu Vasive, Incorporated OVD Class II 2015-12-01
K152211 PCT System Centinel Spine, Inc. NKG Class II 2015-12-01
K153182 SELF- COMPRESSIVE SCREW Neosteo HWC Class II 2015-11-25
K150561 NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System Narang Medical Limited HRS Class II 2015-11-25
K152000 SMV Scientific Bone Plate and Screw System Smv Scientific HRS Class II 2015-11-25
K152494 Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments Zimmer, Inc. JWH Class II 2015-11-25
K153180 Tyber Medical MST Trauma Screw Tyber Medical, LLC HWC Class II 2015-11-25
K151125 AVAflex Vertebral Balloon System Care Fusion HRX Class II 2015-11-24
K152841 Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical Screws Zimmer, Inc. HWC Class II 2015-11-24
K152242 G3¿ Active Plate® Large Fragment System Genesis Fracture Care, Inc. HRS Class II 2015-11-24
K151739 Revision Femoral Stem Lima Corporate S.P.A. LZO Class II 2015-11-23
K153115 Arthrex Univers Apex, Size 5 Stem Arthrex, Inc. KWS Class II 2015-11-23
K151773 CONCORDE Bullet Lumbar Interbody System Medos International SARL MAX Class II 2015-11-20
K152711 Parcus GFS Naked Parcus Medical, LLC MBI Class II 2015-11-20
K152282 Cam Lock Plating System Life Spine, Inc. KWQ Class II 2015-11-20
K151770 Libra Pedicle Screw System Spinal Balance, Inc. NKB Class II 2015-11-20
K152259 InFill Interbody Fusion Device Pinnacle Spine Group, LLC MAX Class II 2015-11-19
K150455 RT2 Trabeculite Titanium Cervical Cage System Rhausler, Inc. ODP Class II 2015-11-19
K152304 Tritanium PL Cage Stryker MAX Class II 2015-11-19
K150684 WASTON General Spinal System Changzhou Waston Medical Appliance Co., Ltd. MNI Class II 2015-11-18
K153031 RANGE/DENALI/MESA Spinal System K2m, Incorporated NKB Class II 2015-11-17
K151004 PULLUP® Adjustable Juxtacortical Fixation Device Sbm Sciences For Bio Materials MBI Class II 2015-11-17
K150790 REDAPT Porous Acetabular Shell and Cemented Liner Smith & Nephew, Inc. LPH Class II 2015-11-16
K151227 KYPHON XPEDE Bone Cement Medtronic NDN Class II 2015-11-16
K152255 BoneCam Suture Anchors Valeris Medical MBI Class II 2015-11-16
K152298 EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOFOAM Tibial Base Microport Orthopedics, Inc. MBH Class II 2015-11-16
K152252 Arthrex iBalance TKA System Arthrex, Inc. MBH Class II 2015-11-16
K151974 Polaris Spinal System Biomet Spine NKB Class II 2015-11-13
K150488 Humelock II Reversible Shoulder System Fx Solutions PHX Class II 2015-11-13
K152277 PIVOX(tm) Oblique Lateral Spinal System Medtronic Sofamor Danek USA, Inc. MAX Class II 2015-11-13
K153075 Klassic Knee System Total Joint Orthopedics, Inc. JWH Class II 2015-11-13
K152757 SIGN Hip Construct (SHC) Sign Fracture Care International HSB Class II 2015-11-13
K152382 Arthrex iBalance TKA System Arthrex, Inc. JWH Class II 2015-11-12
K152976 VLP Mini-Mod Talus Plates Smith & Nephew, Inc. HRS Class II 2015-11-12
K152623 ATLANTIS Anterior Cervical Plate System Medtronic Sofamor Danek USA, Inc. KWQ Class II 2015-11-12
K150211 EzFuze Implant System Vilex IN Tennessee, Inc. HWC Class II 2015-11-10
K151154 FIBERGRAFT BG Morsels Prosidyan, Inc. MQV Class II 2015-11-10
K151819 Integrity Spine Lumbar Interbody Fusion System Integrity Spine Lumbar Interbody Fusion System MAX Class II 2015-11-10
K152248 CD HORIZON Spinal System Medtronic Sofamor Danek USA, Inc. NKB Class II 2015-11-05
K152256 RECON system- Grubber Lapidus-, Platar Lapidus-, Tarsalis Plates and Screws Normed Medizin-Technik GmbH HRS Class II 2015-11-05
K152236 KATOR Suture Anchor Kator, LLC MBI Class II 2015-11-04
K151019 SternaLock® 360 Sternal Closure System Biomet Microfixation HRS Class II 2015-11-03
K152295 Talon DistalFix Antegrade/Retrograde Femoral Nail Orthopedic Designs North America, Inc. HSB Class II 2015-11-03
K151992 FastFrame External Fixation System - Knee Spanning, FastFrame External Fixation System - Damage Control Zimmer, Inc. KTT Class II 2015-11-02
K151886 Acumed Ankle and Small Fragment Base Set Update Acumed, LLC HRS Class II 2015-10-30
K151888 Frontier Medical Devices In-line Orthopedic Cable Cerclage System Frontier Medical Devices, Inc. JDQ Class II 2015-10-30
K152312 RECON system-V-TEK-IVP Plates and Screws Normed Medizin-Technik GmbH HRS Class II 2015-10-30
K151531 MasterLoc Stem Medacta International LZO Class II 2015-10-30
K150568 ARROW Humeral stems size 6 and 16 Fournitures Hospitalieres Industrie PHX Class II 2015-10-29
K152008 Physica PS Knee System Lima Corporate S.P.A. JWH Class II 2015-10-29

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