meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
31
Latest Decision
2018-02-12

Clearances · page 42 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K173710 MotoBAND CP Implant System Crossroads Extremity Systems, LLC HWC Class II 2018-02-12
K171495 Zyston Strut Open Titanium Spacer System Zimmer Biomet Spine, Inc. MAX Class II 2018-02-12
K173025 NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP Expandable XLIF System Nu Vasive, Incorporated MAX Class II 2018-02-08
K173411 Comprehensive Segmental Revision System (SRS) Biomet Manufacturing Corp PHX Class II 2018-02-08
K173537 CONCORDE LIFT™ Medos International SARL MAX Class II 2018-02-08
K173826 THP Hip Fracture Plating System Biomet, Inc. JDO Class II 2018-02-07
K172698 G-Beam Fusion Beaming System Orthofix Srl HWC Class II 2018-02-07
K173882 SeaSpine Mariner Pedicle Screw System SeaSpine Orthopedics Corporation NKB Class II 2018-02-06
K173800 Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage Camber Spine Technologies MQP Class II 2018-02-02
K172105 The Plateau-LO Spacer System Life Spine, Inc. MAX Class II 2018-02-02
K173445 Materialise TKA Guide System Materialise NV JWH Class II 2018-02-02
K172237 Bicera Resorbable Bone Substitute Wiltrom Corporation Limited MQV Class II 2018-02-02
K173849 Triathlon Total Knee System Stryker Orthopaedics MBH Class II 2018-02-02
K172828 Double Medical Cage System Double Medical Technology, Inc. MAX Class II 2018-02-01
K171629 ABCcolla Bone Graft Acro Biomedical Co., Ltd. MQV Class II 2018-02-01
K173047 The Solstice OCT System Life Spine, Inc. NKG Class II 2018-02-01
K173417 Zimmer Persona Personalized Knee System Zimmer, Inc. MBH Class II 2018-01-30
K163081 40-42mm BiPolar Head and 22mm Femoral Head Signature Orthopaedics Pty, Ltd. KWY Class II 2018-01-29
K173814 DeGen Medical E3 MIS Pedicle Screw System Degen Medical NKB Class II 2018-01-29
K172816 TiGer Shark™ System Choicespine, LP MAX Class II 2018-01-26
K172116 Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) Stryker Corporation HRX Class II 2018-01-25
K173521 SeaSpine Cabo ACP (Anterior Cervical Plate) System SeaSpine Orthopedics Corporation KWQ Class II 2018-01-24
K171789 ARROW Reverse Porous Glenoid Fournitures Hospitalieres Industrie PHX Class II 2018-01-23
K180025 Centurion POCT System Orthofix, Inc. NKG Class II 2018-01-22
K173306 EZ Plate Zavation Medical Products, LLC KWQ Class II 2018-01-22
K171312 FortiCore® Nanovis, LLC MAX Class II 2018-01-22
K171273 LINK® BiMobile(TM) Dual Mobility System Waldemar Link GmbH & Co. KG MEH Class II 2018-01-19
K173616 DIP Arthrodesis System In2bones Sas HTY Class II 2018-01-19
K173301 BioSphere MIS Putty (BioSphere MIS) Synergy Biomedical, LLC MQV Class II 2018-01-19
K172696 FORZA® XP Expandable Spacer System Orthofix, Inc. MAX Class II 2018-01-19
K173875 GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert Stelkast, Inc. JWH Class II 2018-01-19
K173215 Choice Spine Laminoplasty™ Fixation System Choicespine, LP NQW Class II 2018-01-19
K173283 Reliance Lumbar IBF System Reliance Medical Systems, LLC MAX Class II 2018-01-19
K171228 Fiji Anchor Sportwelding GmbH MAI Class II 2018-01-19
K173476 Tritanium® TL Curved Posterior Lumbar Cage Stryker MAX Class II 2018-01-18
K171237 FMS VUE II Fluid Management and Tissue Debridement System Medos International SARL HRX Class II 2018-01-18
K173884 Unity Total Knee System Corin U.S.A. Limited JWH Class II 2018-01-17
K172189 Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt Truemed Group, LLC HSB Class II 2018-01-16
K173240 Arthrex PushLock Arthrex, Inc. MAI Class II 2018-01-16
K173641 Activ Ankle Newclip Technics HRS Class II 2018-01-16
K172548 Wiltrom Spinal Fixation System Wiltrom Corporation Limited NKB Class II 2018-01-12
K172438 ARBOR External Fixation System Globus Medical, Inc. KTT Class II 2018-01-12
K171628 HBS2 Headless Bone Screw Stuckenbrock Medizintechnik GmbH HWC Class II 2018-01-12
K172774 T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System Stryker Trauma GmbH HSB Class II 2018-01-12
K170748 GLOBAL UNITE Platform Shoulder System Depuy Ireland UC PHX Class II 2018-01-11
K172205 ExoToe Staple Exotoe, LLC JDR Class II 2018-01-11
K172336 Smith & Nephew Patient Matched Cutting Blocks Smith & Nephew, Inc. JWH Class II 2018-01-10
K171421 VERTICALE® Posterior Spinal Fixation System/VERTICALE® System Silony Medical GmbH NKB Class II 2018-01-10
K173508 Everest Spinal System K2m NKB Class II 2018-01-09
K172212 MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ Ctl Medical Corporation ODP Class II 2018-01-09
K172183 Guided Growth Plate System Plus Orthofix Srl OBT Class II 2018-01-09
K173293 EVOS Small Fragment Upper Extremity Plates Smith & Nephew, Inc. HRS Class II 2018-01-08
K173159 Cervical Spinal Truss System (CSTS) Interbody Fusion Device 4Web, Inc. ODP Class II 2018-01-08
K173278 ToggleLoc System Biomet, Inc. MBI Class II 2018-01-05
K171372 Alians Elbow Locking Plating System Newclip Technics HRS Class II 2018-01-04
K172456 Bone Screws 6.5mm Lima Corporate S.P.A. LPH Class II 2018-01-04
K172502 Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate Biomet Manufacturing Corp PHX Class II 2018-01-03
K173702 Juliet Ti LL Spineart MAX Class II 2018-01-03
K173102 Reliance Cervical IBF System Reliance Medical Systems, LLC ODP Class II 2017-12-29
K171108 AUTOBAHN Nailing System Globus Medical, Inc. HSB Class II 2017-12-29
K170165 Osteo-P Bone Graft Substitute Molecular Matrix, Inc. MQV Class II 2017-12-29
K173652 Piccolo Composite Nailing System CarboFix Orthopedics , Ltd. HSB Class II 2017-12-28
K171269 X-PSI Knee System Orthosoft Inc (D/B/A Zimmer Cas) JWH Class II 2017-12-28
K173073 AltiVate Anatomic to Reverse Conversion Module Encore Medical L.P. PHX Class II 2017-12-26
K173008 SCS 17-01 Anika Therapeutics, Inc. MQV Class II 2017-12-26
K172688 Align Radial Head System Skeletal Dynamics, LLC KWI Class II 2017-12-22
K172383 Arthrosurface Bone Screws Arthrosurface, Inc. HWC Class II 2017-12-22
K172785 CONQUEST FN Smith & Nephew JDO Class II 2017-12-22
K172330 Blustone Synergy Silica System Blustone Synergy MQP Class II 2017-12-21
K172185 Tyber Medical PT Interbody Spacer System Tyber Medical, LLC ODP Class II 2017-12-21
K172467 OMNI ARC Anteverted Neck Hip Stem Omnilife Science LZO Class II 2017-12-21
K171434 ROCCIA® MultiLIF Silony Medical GmbH MAX Class II 2017-12-21
K173375 Anterior Cervical Plate System Evolution Spine, LLC KWQ Class II 2017-12-21
K172973 Life Spine Foot and Ankle Plating System Life Spine, Inc. HRS Class II 2017-12-21
K171848 FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO Corpectomy Spacers, SUSTAIN Spacers, COALITION Spacers, PATRIOT Lumbar Spacers, PATRIOT Cervical Spacers, ALTERA Spacers, RISE Spacers, CALIBER Spacers, ELSA Spacers, LATIS Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, MAGNIFY Spacers, INDEPENDENCE Spacers Globus Medical, Inc. MAX Class II 2017-12-21
K172926 SeaSpine Vu cPOD, Zuma-C, Complete Cervical SeaSpine Orthopedics Corporation ODP Class II 2017-12-21
K170972 Apex Tibial Nailing System Orthoxel HSB Class II 2017-12-20
K173125 T2 STRATOSPHERE™ Expandable Corpectomy System Medtronic Sofamor Danek MQP Class II 2017-12-20
K172886 Breakaway Screw System Paragon 28 HRS Class II 2017-12-20
K173115 COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS Globus Medical, Inc. ODP Class II 2017-12-20
K173182 ProLift® Expandable System Life Spine, Inc. MAX Class II 2017-12-20
K171834 G Surgical OCT Spinal System G Surgical, LLC NKG Class II 2017-12-19
K173130 Reform® Midline Cortical Screw System Precision Spine, Inc. NKB Class II 2017-12-19
DEN160062 IlluminOss Bone Stabilization System Illminoss Medical, Inc. QAD Class II 2017-12-19
K171858 Sidus Stem-Free Shoulder Zimmer GmbH PKC Class II 2017-12-18
K172888 EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, EIT Cellular Titanium® ALIF Cages Eit Emerging Implant Technologies GmbH MAX Class II 2017-12-15
K172573 ReBOSSIS85 Orthorebirth Co., Ltd. MQV Class II 2017-12-15
K172594 Proficient® Posterior Cervical Spine System Spine Wave, Inc. NKG Class II 2017-12-15
K172465 Idys™ TLIF 3DTi Cages Clariance, Sas MAX Class II 2017-12-15
K172350 AxSOS 3 Ti Stryker GmbH HRS Class II 2017-12-15
K173550 Akros FibuLink™ Syndesmosis Repair Kit Akros Medical HTN Class II 2017-12-14
K172676 NuVasive® Modulus-C Interbody System Nu Vasive, Incorporated ODP Class II 2017-12-14
K172009 Cascadia Interbody System K2m, Inc. MAX Class II 2017-12-14
K170389 TAURUS PEEK Cage System Medyssey USA, Inc. MAX Class II 2017-12-14
K173013 WishBone K-Wire System Wishbone Medical, Inc. HTY Class II 2017-12-14
K170414 Arthrex Univers Revers Apex Humeral Stems Arthrex, Inc. PHX Class II 2017-12-14
K173286 Cannulated Screw Internal Fixation System Life Spine, Inc. HWC Class II 2017-12-14
K172349 InFill® Interbody Fusion Device Pinnacle Spine Group, LLC MAX Class II 2017-12-14
K173524 ANAX 5.5™ Spinal System U&I Corporation NKB Class II 2017-12-13
K172651 FMP Extended Liners Encore Medical L.P. OQG Class II 2017-12-13

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