meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
35
Latest Decision
2017-04-10

Clearances · page 47 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K163386 Keos Lumbar IBFD Keos MAX Class II 2017-04-10
K162068 ARROW Anatomical Porous glenoid Fournitures Hospitalieres Industrie MBF Class II 2017-04-10
K163265 Kepler II Orbbo Surgical, LLC ODP Class II 2017-04-07
K163361 ANTHEM™ Fracture System Globus Medical, Inc. HRS Class II 2017-04-07
K163246 Leva Anterior Expandable Spacer System Spine Wave, Inc. MAX Class II 2017-04-06
K162927 PRECICE UNYTE CoCr System Nuvasive Specialized Orthopedics, Inc. HSB Class II 2017-04-06
K161332 NILE Proximal Fixation Spinal System K2m, Inc. OWI Class II 2017-04-05
K163363 SurgTech Thoracolumbosacral (TLS) Posterior Fixation System Surgtech, Inc. NKB Class II 2017-04-05
K170347 CD HORIZON™ Fenestrated Screw Set Medtronic Sofamor Danek USA NKB Class II 2017-04-04
K170040 BePOD Cannulated Arthrodesis Screws Fournitures Hospitalieres Industrie HWC Class II 2017-04-04
K162206 Zavation IBF Zavation, LLC MAX Class II 2017-04-04
K163303 OsteoMed ExtremiFix Mid and Large Screw System Osteomed, LLC HWC Class II 2017-04-04
K162241 TITAN 3-D™ Wedge System Paragon 28 PLF Class II 2017-04-03
K161635 AMIStem-H Proximal Coating Medacta International S.A. LZO Class II 2017-03-31
K170098 ICONIX TT All Suture Anchor Stryker MBI Class II 2017-03-31
K163096 GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System Gpc Medical Limited NKB Class II 2017-03-31
K170243 LOSPA IS TLIF & DLIF Cages Corentec Co., Ltd. MAX Class II 2017-03-31
K170310 Alians Clavicle range Newclip Technics HRS Class II 2017-03-30
K170271 NuVasive(r) Monolith Corpectomy System Nu Vasive, Incorporated MQP Class II 2017-03-30
K162995 Ibis® Pedicle Screw System Ortho Development Corporation NKB Class II 2017-03-30
K170327 Parcus SLiK Anchors Parcus Medical MBI Class II 2017-03-30
K162124 Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins DePuy Synthes JDP Class II 2017-03-29
K162693 VertebraLINK Fusion Platform Facetlink Dba Linkspine MAX Class II 2017-03-29
K170654 USS System Synthes USA Products, LLC NKB Class II 2017-03-29
K163700 Bodycad Unicompartmental Knee System Bodycad Laboratories, Inc. HSX Class II 2017-03-29
K163425 NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System Narang Medical USA Corporation HRS Class II 2017-03-24
K163491 NuVasive CoRoent Small Interbody System Nu Vasive, Incorporated ODP Class II 2017-03-24
K170530 Butrex Lumbar Buttress Plating System X-Spine Systems, Inc. KWQ Class II 2017-03-22
K163323 Dolphix® External Fixation System MR Conditional Citieffe S.R.L. KTT Class II 2017-03-20
K163488 Flex-Thread Clavicle Pin System Intrafuse, LLC HSB Class II 2017-03-20
K162898 Olecranon Plating System Miami Device Solutions, LLC HRS Class II 2017-03-17
K170501 CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver Conmed Corporation MAI Class II 2017-03-17
K163471 Kalitec Direct InSePtion™ MIS Fixation System Kalitec Direct, LLC PEK Class II 2017-03-16
K163003 Y3 Proximal Femoral Plate System Pega Medical, Inc. HRS Class II 2017-03-16
K162070 JOINIX CANNULAR SYSTEM Aju Pharm Co., Ltd. HRX Class II 2017-03-16
K163230 NuVasive Modulus XLIF Interbody System Nu Vasive, Incorporated MAX Class II 2017-03-16
K161840 LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated Waldemar Link GmbH & Co. KG LZO Class II 2017-03-16
K170455 MectaLIF Anterior Stand Alone Medacta International S.A. OVD Class II 2017-03-16
K161705 U2 Total Knee System E-XPE products United Orthopedic Corporation JWH Class II 2017-03-16
K163364 MOJAVE Expandable Interbody System K2m MAX Class II 2017-03-15
K162429 ZipE Knotless Tissue Repair and Attachment Devices Ziptek, LLC MAI Class II 2017-03-13
K163039 ORTHOLOC® 3Di Small Bones Plating Wrightmedicaltechnologyinc HRS Class II 2017-03-13
K170512 Altus Spine Titanium Interbody Fusion System Altus Partners, LLC MAX Class II 2017-03-10
K163474 CAVUX CervicalCage-L SA System Providence Medical Technology, Inc. OVE Class II 2017-03-10
K162733 iFuse Implant System® - iFuse-3D implant SI-BONE, Inc. OUR Class II 2017-03-10
K162412 Hoggan Scientific® microFET2™ Hoggan Scientific, LLC LBB Class II 2017-03-09
K170528 Sterispine™ PS Safe Orthopaedics NKB Class II 2017-03-09
K163604 SeaSpine® Daytona® Small Stature Spinal System SeaSpine Orthopedics Corporation NKB Class II 2017-03-09
K170126 NuVasive® Reline® 4.5-5.0 System Nu Vasive, Incorporated NKB Class II 2017-03-09
K170124 Level One Hand Plating System KLS Martin L.P. HRS Class II 2017-03-09
K163409 Rampart(TM) T Lumbar Interbody Fusion Device Spineology, Inc. MAX Class II 2017-03-08
K163489 OrthoSolutions 'System26' Bone Screws Ortho Solutions UK Limited HWC Class II 2017-03-08
K170346 PRECICE Intramedullary Limb Lengthening System Nuvasive Specialized Orthopedics, Inc. HSB Class II 2017-03-07
K162325 Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw Exactech, Inc. PHX Class II 2017-03-06
K162033 SALVATION External Fixation System Wright Medical KTT Class II 2017-03-06
K162035 GMK Sphere Medacta International S.A. JWH Class II 2017-03-06
K170350 ToeMATE® Hammertoe Correction System Arthrosurface, Inc. HWC Class II 2017-03-03
K162575 Z-LINKPC System Zavation, LLC NKG Class II 2017-03-03
K163497 EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt Encore Medical L.P. KWZ Class II 2017-03-02
K162026 EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions Microport Orthopedics, Inc. JWH Class II 2017-03-01
K163543 Biomet Fusion System Zimmer Biomet Spine, Inc. OVD Class II 2017-02-28
K163038 EPIC Extremity Snap-Off Screw Epic Extremity, LLC HWC Class II 2017-02-28
K163032 Kyphon Xpede Bone Cement Medtronic, Inc. NDN Class II 2017-02-27
K162903 Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies Exactech, Inc. KWT Class II 2017-02-27
K161371 Sonoma Fifth Metatarsal Repair System Sonoma Orthopedic Products, Inc. HSB Class II 2017-02-24
K163056 Revolution™ Spinal Fixation System Intelligent Implant Systems, LLC NKB Class II 2017-02-24
K161859 MagnetOs Xpand Biotechnology BV MQV Class II 2017-02-24
K170265 GRAVITYTM PEEK-OPTIMA Suture Anchor Wrightmedicaltechnologyinc MBI Class II 2017-02-23
K170240 Truliant Femoral Components Exactech, Inc. JWH Class II 2017-02-23
K152022 SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Spacers, MONUMENT™ Spacers, ALTERA™ Spacers, MAGNIFY™ Spacers, InterContinental® Plate-Spacer Globus Medical, Inc. MAX Class II 2017-02-22
K162800 BLUEPRINT Patient Specific Instrumentation Tornier S.A.S. KWS Class II 2017-02-22
K162795 PROPHECY INVISION Preoperative Navigation Alignment System Wrightmedicaltechnologyinc HSN Class II 2017-02-22
K161120 SMR TT Metal Back Glenoid, Bone Graft instruments Lima Corporate S.P.A. PHX Class II 2017-02-21
K162032 Arrowhead Mini-Rail Fixator Arrowhead De, LLC KTT Class II 2017-02-21
K162391 AlignMATE™ Lapidus Arthrodesis System Arthrosurface, Inc. HRS Class II 2017-02-21
K162841 VariAx Distal Radius Plating System, VariAx 2 System Stryker GmbH HRS Class II 2017-02-21
K161894 SurgTech Trauma System Surgtech, Inc. HWC Class II 2017-02-21
K162824 Z-Span Plate System Zavation, LLC KWQ Class II 2017-02-17
K163037 Intra medullary endo-transilluminating device (iMET device) WeMED Bio-Tech, Inc. HRX Class II 2017-02-17
K161996 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE Amend Surgical, Inc. MQV Class II 2017-02-16
K161616 DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw Synthes USA Products, LLC HWC Class II 2017-02-16
K162402 4CIS® Marlin ACIF Cage System Solco Biomedical Co., Ltd. ODP Class II 2017-02-16
K162849 Huvex Interspinous Fixation System Dio Medical Co., Ltd. PEK Class II 2017-02-16
K162760 Spine Wave Anterior Cervical Spine System Spine Wave, Inc. OVE Class II 2017-02-16
K163602 Kepler I Cervical Plate System Orbbo Surgical, LLC KWQ Class II 2017-02-16
K170163 Erisma® LP Spinal Fixation System Clariance, Sas NKB Class II 2017-02-14
K162860 MCS Bone Graft Bioventus, LLC MQV Class II 2017-02-13
K163487 Ultima HA Coated Half Pins and Wire Vilex IN Tennessee, Inc. JDW Class II 2017-02-13
K162697 Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal Custom Orthopaedic Solutions, Inc. KWS Class II 2017-02-10
K162321 EasyClip Xpress Restore Surgical, LLC Dba Instratek JDR Class II 2017-02-10
K161226 Revision Femoral Stem Lima Corporate S.P.A. LZO Class II 2017-02-10
K161861 APTUS® Coronoid 2.0 Medartis AG HRS Class II 2017-02-09
K163046 DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long DePuy Synthes HRS Class II 2017-02-09
K162918 Atlas Spine Expandable Interbody System Atlas Spine, Inc. MAX Class II 2017-02-09
K161334 RASL Repair Kit Radicle Orthopaedics, Inc. HWC Class II 2017-02-09
K163566 Hubble I System Orbbo Surgical, LLC NKB Class II 2017-02-09
K162639 Proficient™ Posterior Cervical Spine System Spine Wave, Inc. NKG Class II 2017-02-07
K170072 Fitmore® Hip Stem Zimmer GmbH KWY Class II 2017-02-07
K163061 Altus Spine Cervical Plate System Altus Partners, LLC KWQ Class II 2017-02-06
K162283 DCM Kyphoplasty System Dragon Crown Medical Co., Ltd. NDN Class II 2017-02-06

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