meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
34
Latest Decision
2017-02-03

Clearances · page 48 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K162439 AxSOS 3 Ti; Stryker Plating System Stryker GmbH HRS Class II 2017-02-03
K170061 ProMIS™ Fixation System Premia Spine, Ltd. NKB Class II 2017-02-02
K163428 HA Minuteman G3-R MIS Fusion Plate Spinal Simplicity PEK Class II 2017-02-02
K163440 Stealth Staple System First Ray, LLC JDR Class II 2017-02-01
K161360 U2 Total Knee System, PSA Tibial Insert United Orthopedic Corporation JWH Class II 2017-02-01
K162726 Exactech® Equinoxe® Preserve Stem Exactech, Inc. PHX Class II 2017-02-01
K161587 Memodyn Staple Austin & Associates, Inc./Telos Medical Equipment JDR Class II 2017-02-01
K161279 Life Spine Metatarsal Hemi Implant Life Spine, Inc. KWD Class II 2017-02-01
K162879 Elite Expandable Interbody Fusion Device Spineology, Inc. MAX Class II 2017-01-30
K161303 dynaMX™ Compression Plate Mx Orthopedics, Corp. HRS Class II 2017-01-26
K163368 FITBONE TAA Wittenstein Intens GmbH HSB Class II 2017-01-26
K163044 ORTHOLOC® 3Di Ankle Fracture Plating System Wrightmedicaltechnologyinc HRS Class II 2017-01-26
K162587 ROCCIA® ACIF Silony Medical GmbH ODP Class II 2017-01-26
K163258 CrossFT Knotless Suture Anchor with Disposable Driver Conmed Corporation MBI Class II 2017-01-25
K161273 StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis Biomet, Inc. MBB Class II 2017-01-25
K162786 PASS LP Spinal System Medicrea International SA NKB Class II 2017-01-25
K160976 Altus Spine Interbody Fusion System Altus Partners, LLC MAX Class II 2017-01-25
K161466 ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System Orthofix Srl HSB Class II 2017-01-24
K170074 nvc Nvision Biomedical Technologies, LLC ODP Class II 2017-01-24
K163014 AOS Small Bone Nailing System Advanced Orthopaedic Solutions, Inc. (Aos) HSB Class II 2017-01-24
K162618 CONCORD Plus Radiopaque Bone Cement Globus Medical, Inc. NDN Class II 2017-01-23
K161231 Facilis™ Spinal System Baui Biotech Co., Ltd. NKB Class II 2017-01-23
K161414 Anatomic Total Knee System Amplitude JWH Class II 2017-01-19
K162764 JAZZ FRAME SYSTEM Implanet, S.A. NKB Class II 2017-01-19
K161904 GEO Bone Screw System Gramercy Extremity Orthopeidics, LLC HWC Class II 2017-01-18
K163156 SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides Materialise NV PBF Class II 2017-01-18
K163310 NovaBone IRM Novabone Products, LLC MQV Class II 2017-01-18
K162121 Siconus SI Joint Fixation System Camber Spine Technologies OUR Class II 2017-01-18
K162455 Humelock Reversed Shoulder Fx Solutions PHX Class II 2017-01-17
K162775 Legion Cone System Smith & Nephew, Inc. JWH Class II 2017-01-13
K162694 Ayers Rock Cervical interbody fusion system Spineway ODP Class II 2017-01-12
K162179 osteo-WEDGE II ® Open Wedge Bone Locking Plate System Graham Medical Technologies, LLC Dba Gramedica HRS Class II 2017-01-10
K162805 Akros Fibulink Syndesmosis Repair Kit Akros Medical HTN Class II 2017-01-10
K161641 LOSPA IS ACP System Corentec Co., Ltd. KWQ Class II 2017-01-05
K161637 Poseidon OCT Spinal Fixation System Medyssey USA, Inc. NKG Class II 2017-01-05
K162084 MOTO Partial Knee System Medacta International S.A. HSX Class II 2017-01-03
K162702 Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table Stl International, Inc. HST Class I 2016-12-30
K163180 Hubble II Orbbo Surgical, LLC MAX Class II 2016-12-29
K162531 STERISPINE CC Safe Orthopaedics OVE Class II 2016-12-29
K163028 Medline ReNewal Reprocessed Stryker External Fixation Devices Surgical Instrument Service and Savings, Inc. JEC Class II 2016-12-28
K160972 Gexfix External Fixation Gexfix International Corp. KTT Class II 2016-12-28
K161789 BLUEPRINT Patient Specific Instrumentation Tornier S.A.S. KWS Class II 2016-12-27
K162446 FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System Orthofix, Inc. MAX Class II 2016-12-22
K161127 The Small PLATEAU (PLATEAU-C) Spacer System Life Spine, Inc. ODP Class II 2016-12-22
K161032 neon3™ universal OCT spinal stabilization Ulrich GmbH & Co. KG NKG Class II 2016-12-22
K160982 Sphynx™ Eden Spine, LLC KWQ Class II 2016-12-22
K163311 GMK Revision Femoral Distal Augmentation Medacta International S.A. KRO Class II 2016-12-21
K162003 IMSE Cervical Cage The Institute of Musculoskeletal Science & Education ODP Class II 2016-12-21
K163086 VLP MINI-MOD 2.0mm Column Plates Smith & Nephew, Inc. HRS Class II 2016-12-21
K160879 CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems Medos International Sàrl PML Class II 2016-12-20
K163301 CD HORIZON® Spinal System Medtronic Sofamor Danek USA, Inc. NKB Class II 2016-12-20
K160771 Destiknee Total Knee System Meril Healthcare Private Limited JWH Class II 2016-12-19
K160515 PS2 Knee System Consensus Orthopedics, Inc. JWH Class II 2016-12-19
K161259 KLS Martin Cannulated Headless Screws KLS Martin L.P. HWC Class II 2016-12-19
K162638 CETRA Anterior Cervical Plate System Orthofix, Inc. KWQ Class II 2016-12-16
K161060 Arthrex iBalance UKA System Vitamin E Tibial Bearing Arthrex, Inc. HSX Class II 2016-12-15
K161233 OXINIUM DH Fermoral Heads Smith & Nephew, Inc. MBL Class II 2016-12-14
K161755 Integrity-SI TM Fusion System Coorstek Medical OUR Class II 2016-12-14
K162134 ENNOVATE Spinal System Aesculap Implant Systems, LLC NKB Class II 2016-12-14
K162680 SOVEREIGN® Spinal System Medtronic Sofamor Danek USA, Inc. OVD Class II 2016-12-14
K162327 COUGAR® LS Lateral Cage System and COUGAR® System Medos International SARL MAX Class II 2016-12-12
K162829 Medline UNITE® Ankle Fracture Plating System Medline Industries, Inc. HRS Class II 2016-12-09
K162974 Biomet Microfixation RibFix Blu Thoracic Fixation System Biomet Microfixation HRS Class II 2016-12-09
K162194 MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System Medicrea International SA KWQ Class II 2016-12-08
K162912 VIPER PRIME™ additions to the VIPER® System Medos International SARL NKB Class II 2016-12-08
K163034 SUTUREFIX Curved Suture Anchor Smith and Nephew, Inc. MBI Class II 2016-12-07
K160222 OIC Cervical PEEK Spacer The Orthopaedic Implant Company ODP Class II 2016-12-07
K161809 ShurFit CpTi-HA ACIF Interbody Fusion System Precision Spine, Inc. ODP Class II 2016-12-06
K162127 Bencox M Stem Lateralized & Bencox Mirabo Cup System Corentec Co., Ltd. LPH Class II 2016-12-05
K160946 4.0 and 6.5 Cancellous Bone Screw and Washer Smv Scientific HWC Class II 2016-12-05
K162066 Reliance Spinal Screw System Reliance Medical Systems, LLC MNH Class II 2016-12-02
K160566 Cerasorb Ortho Foam Curasan AG MQV Class II 2016-12-02
K160157 LOSPA Modular Knee System Corentec Co., Ltd. JWH Class II 2016-12-01
K162351 SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device SeaSpine Orthopedics Corporation OVD Class II 2016-12-01
K162211 AccuFit Lateral Plate System Precision Spine, Inc. KWQ Class II 2016-11-28
K161863 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA) Stryker GmbH KWS Class II 2016-11-23
K161696 aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 Aap Implantate AG HRS Class II 2016-11-23
K160545 GAP ENDO-EXO MEDULLARY SYSTEM Pega Medical, Inc. HSB Class II 2016-11-23
K161264 TRIGEN Low Profile Bone Screws Smith & Nephew, Inc. HSB Class II 2016-11-23
K162103 Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™) Choicespine, LP MAX Class II 2016-11-23
K163007 Biomet Microfixation SternaLock 360 Sternal Closure System Biomet Microfixation HRS Class II 2016-11-23
K162300 Reform® POCT System Precision Spine, Inc. NKG Class II 2016-11-22
K161747 LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5 Aap Implantate AG HRS Class II 2016-11-22
K161993 Leva® Anterior Interbody System Spine Wave, Inc. OVD Class II 2016-11-22
K161778 ToeTac™ 10° Hammertoe Fixation System Restore Surgical, LLC Dba Instratek HWC Class II 2016-11-22
K162024 AltiVate Anatomic Shoulder System Encore Medical L.P. KWS Class II 2016-11-21
K161782 Arthrex Univers Revers Shoulder Prosthesis System Arthrex, Inc. HSD Class II 2016-11-21
K162220 DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage Dio Medical Co., Ltd. ODP Class II 2016-11-21
K162198 GFS Ultimate Parcus Medical, LLC MBI Class II 2016-11-18
K162078 EVOS Small Fragment Plating System Smith & Nephew, Inc. HRS Class II 2016-11-18
K162160 Preference Elite Pedicle Screw System Amedica Corporation NKB Class II 2016-11-18
K162232 MOSS 100 Pedicle Screw System Biedermann Motech GmbH & Co. KG NKB Class II 2016-11-17
K160923 REDAPT Anteverted Cemented Liner Smith & Nephew, Inc. JDI Class II 2016-11-17
K162431 Luna 3D Interbody Fusion System Benvenue Medical, Inc. MAX Class II 2016-11-17
K160959 Xsert Lumbar Expandable Interbody System X-Spine Systems, Inc. MAX Class II 2016-11-17
K162379 CD HORIZON® Spinal System Medtronic Sofamor Danek USA, Inc. NKB Class II 2016-11-16
K160663 Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF) Evolution Spine, LLC MAX Class II 2016-11-16
K161597 Tyber Medical BioTy® Nanotopography Trauma Screw Tyber Medical, LLC HWC Class II 2016-11-16
K160791 AmorChem Titanium Porous Fixation Device Amorchem Holdings, Inc. HWC Class II 2016-11-15
K161665 VLP Wrist Fracture System Smith & Nephew, Inc. HRS Class II 2016-11-15

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