meddevicedb.com FDA Device Reference

Review Panel

Orthopedic FDA 510(k) Clearances & Devices

Cleared Devices
17,115
Product Codes (page)
35
Latest Decision
2015-06-17

Clearances · page 56 of 172

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K143622 dynaMX Compression Staple Mx Orthopedics, Corp. JDR Class II 2015-06-17
K150119 PALACOS R pro Heraeus Medical GmbH LOD Class II 2015-06-17
K150994 NuVasive CoRoent Thoracolumbar Implants Nu Vasive, Incorporated PHM Class II 2015-06-17
K150730 Zimmer PSI Shoulder System Zimmer KWT Class II 2015-06-16
K150184 Dymaxeon Spine System Back 2 Basics Direct, LLC NKB Class II 2015-06-15
K150496 Total Knee Arthroplasty System Responsive Orthopedics, LLC JWH Class II 2015-06-12
K142835 Iliad Pedicle Screw System and Zenius Pedicle Screw System Medyssey USA, Inc. NKB Class II 2015-06-12
K150582 Vertaplex® High Viscosity (HV) Radiopaque Bone Cement Stryker Corporation NDN Class II 2015-06-12
K150376 Sonoma Cancellous Bone Screw and Washer Sonoma Orthopedics Products, Inc. HWC Class II 2015-06-12
K150135 DIVERGENCE-L Anterior/Oblique Lumbar Fusion System Medtronic Sofamor Danek USA, Inc. MAX Class II 2015-06-11
K142645 Avenue T TLIF Cage Ldr Spine USA, Inc. OVD Class II 2015-06-11
K150362 NuVasive CoRoent Small Interbody System Nu Vasive, Incorporated ODP Class II 2015-06-11
K141332 Captiva Spine SmartLOX Cervical Plate System Captiva Spine KWQ Class II 2015-06-11
K143572 Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, Intersomatic Transforaminal - TLIF PEEK Osteomed Implantes, Ltda ODP Class II 2015-06-10
K150867 Affixus Tibial Nailing System Biomet, Inc. HSB Class II 2015-06-10
K142906 APTUS Wrist 2.5 System Medartis AG HRS Class II 2015-06-09
K142269 Reliance Cervical IBF System Reliance Medical Systems, LLC ODP Class II 2015-06-09
K150753 OASYS System Stryker Corporation KWP Class II 2015-06-09
K142559 ELEVATE Spinal System Medtronic Sofamor Danek USA, Inc. MAX Class II 2015-06-09
K150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti Centinel Spine, Inc. OVD Class II 2015-06-08
K150294 DPZ Pedicular Fixation System Osteomed Implantes, Ltda MNI Class II 2015-06-05
K143002 Metallic Locking Bone Plate and Screw System Changzhou Dingjian Medical Appliance Co., Ltd. HRS Class II 2015-06-05
K150581 Tritium Sternal Cable Plate System Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) JDQ Class II 2015-06-04
K150552 ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS Globus Medical, Inc. NKG Class II 2015-06-04
K150443 ToeTac Hammertoe Fixation System Restore Surgical, LLC Dba Instratek HWC Class II 2015-06-04
K150851 Sure Lok Mini Posterior Cervical/Upper Thoracic System Precision Spine, Inc. KWP Class II 2015-06-04
K151215 Mercury Spinal System Spinal Elements, Inc. NKB Class II 2015-06-03
K150570 ANAX OCT Spinal System U&I Corporation NKG Class II 2015-06-03
K143204 AOS Clavicle Intramedullary Device Advanced Orthopaedic Solutions, Inc. HSB Class II 2015-06-03
K143321 ITST Intertrochanteric/Subtrochanteric Fixation System Zimmer, Inc. HSB Class II 2015-05-29
K150885 MAGEC 2 Spinal Bracing and Distraction System Ellipse Technologies, Incorporated PGN Class II 2015-05-29
K143496 Piccolo Composite Plate System CarboFix Orthopedics , Ltd. HRS Class II 2015-05-29
K150544 Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System Aesculap Implant Systems, LLC JWH Class II 2015-05-29
K150890 Exactech Optetrak Logic CC Exactech, Inc. JWH Class II 2015-05-29
K143028 Azure Anterior Cervical Plate System Orthofix, Inc. KWQ Class II 2015-05-29
K142478 opti-Toe Graham Medical Technologies, LLC (D.B.A.Gramedica) HTY Class II 2015-05-29
K142586 Captiva Spine FuselOX Cervical IBF System Captiva Spine ODP Class II 2015-05-28
K143256 SMR Modular Glenoid Lima Corporate S.P.A. KWS Class II 2015-05-28
K150130 Ascendant TM Cervical Spacer System Exactech, Inc. ODP Class II 2015-05-28
K151173 Biomet Microfixation RibFix Blu Thoracic Fixation System Biomet Microfixation HWC Class II 2015-05-26
K150471 CalcaNail Orthopedic Arthrodesis Nail Fournitures Hospitalieres Industrie HSB Class II 2015-05-22
K150463 CalcaNail Orthopedic Nail Fournitures Hospitalieres Industrie HSB Class II 2015-05-22
K143683 APEX-DL Spine System Spinecraft, LLC NKB Class II 2015-05-22
K150600 Response 5.5/6.0 Spine System OrthoPediatrics Corp. NKB Class II 2015-05-22
K143740 Battalion Universal Spacer System Alphatec Spine, Inc. MAX Class II 2015-05-22
K143660 Milagro / Milagro Advance Interference Screw Depuy Mitek, A Johnson & Johnson Company MAI Class II 2015-05-21
K150090 Zimmer Persona Personalized Knee System Zimmer, Inc. MBH Class II 2015-05-20
K142724 BIOFOAM Bone Wedge Wrightmedicaltechnologyinc HRS Class II 2015-05-20
K150417 ASTRA SPINE SYSTEM Spinecraft, LLC NKB Class II 2015-05-19
K150061 Lucent; Lucent Ti-Bond Systems Spinal Elements, Inc. MAX Class II 2015-05-19
K150822 Centurion POCT System Orthofix, Inc. NKG Class II 2015-05-15
K143242 Rebel 3DKNEE System Encore Medical L.P. JWH Class II 2015-05-15
K150424 JuggerStitch Meniscal Repair Device Biomet Manufacturing Corp MBI Class II 2015-05-15
K150521 Interbody Fusion (IBF)/Vertebral Body Replacement(VBR) System Rti Surgical, Inc. Dba Rti Biologics ODP Class II 2015-05-15
K151078 Arthrex RetroFusion Screw Arthrex, Inc. HWC Class II 2015-05-15
K150458 Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere Exactech, Inc. PHX Class II 2015-05-14
K142504 SpineFrontier Lumbar Interbody Fusion Device System Spinefrontier, Inc. MAX Class II 2015-05-13
K150185 Mont Blanc Spinal System Spineway NKB Class II 2015-05-12
K150675 Dorsal Spanning Plate Skeletal Dynamics, LLC HRS Class II 2015-05-12
K150539 OASYS System Stryker Corporation NKG Class II 2015-05-12
K150152 The Octane Straight Intervertebral Fusion Device, Ti Coated Exactech, Inc. MAX Class II 2015-05-11
K143647 Renovis Surgical Hip Replacement System Renovis Surgical Technologies, Inc. OQG Class II 2015-05-11
K150125 Elite Nitinol Fixation System Biomedical Enterprises, Inc. JDR Class II 2015-05-11
K150126 Life Spine Cannulated Screws Life Spine, Inc. HWC Class II 2015-05-11
K150213 Subtalar Spacer System (STS) Wrightmedicaltechnologyinc HWC Class II 2015-05-08
K150772 Snap-Off Self-Compressive Screw Neosteo HWC Class II 2015-05-08
K142487 Chesapeake Stabilization System K2m, Inc. OVD Class II 2015-05-07
K150359 Tensyn Plug Dallen Medical, Inc. HTN Class II 2015-05-07
K142744 Mecta-C TiPEEK Medacta International ODP Class II 2015-05-07
K150954 Elite L Expandable Lumbar Fusion System Innova Spinal Technologies, LLC MAX Class II 2015-05-07
K143759 JAZZ System Implanet, S.A. OWI Class II 2015-05-07
K150036 Blue Mountain Cervical Plate System Spineway KWQ Class II 2015-05-07
K150007 Modified Bencox Hip System Corentec Co., Ltd. LPH Class II 2015-05-04
K142212 Pyrenees Cervical Plate System K2m, Inc. KWQ Class II 2015-05-01
K150818 Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System Zimmer, Inc. KTT Class II 2015-05-01
K150626 Rush Medullary Pins Zimmer, Inc. HTY Class II 2015-05-01
K150522 G7 Dual Mobility System Biomet, Inc. LPH Class II 2015-05-01
K150913 INCITE ANCHORED CERVICAL INTERBODY DEVICE Incite Innovation OVE Class II 2015-04-30
K150649 G3 Active Plate Large Fragment System Genesis Fracture Care, Inc. HRS Class II 2015-04-30
K142392 Zavation Posterior LEIF Zavation, LLC MAX Class II 2015-04-29
K150283 Republic Spine Dark Star Spinal System Republic Spine, LLC MNH Class II 2015-04-29
K142867 Reliance Posterior Cervical-Thoracic System Reliance Medical Systems, LLC KWP Class II 2015-04-29
K150974 aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping, Titanium Aap Implantate AG HWC Class II 2015-04-29
K150520 DARCO Locking Bone Plate System Wrightmedicaltechnologyinc HRS Class II 2015-04-29
K150456 Arthrex Plates, Screws, and Staples Arthrex, Inc. HRS Class II 2015-04-29
K150252 PHALINX Hammertoe System Wrightmedicaltechnologyinc HWC Class II 2015-04-29
K150579 Cardinal Health External Fixation System Cardinalhealth KTT Class II 2015-04-29
K150188 SMV Scientific 4.5 mm Bone Screws Summit Medventures HWC Class II 2015-04-29
K143595 NuVasive(R) CCX-L Interbody System Nu Vasive, Incorporated MAX Class II 2015-04-29
K150254 Streamline OCT Occipito-Cervico-Thoracic System Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) KWP Class II 2015-04-28
K150460 KYPHON (R) HV-R(R) Bone Cement Medtronic Sofamor Danck USA, Inc. NDN Class II 2015-04-28
K150017 SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System Spinefrontier, Inc. OUR Class II 2015-04-24
K143684 NuVasive Reline System Nu Vasive, Incorporated NKB Class II 2015-04-23
K150656 PRECICE Intramedullary Limb Lengthening System Ellipse Technologies, Incorporated HSB Class II 2015-04-23
K140348 INTERBODY CAGE Eisertech, LLC MAX Class II 2015-04-23
K142253 SOLSTICE OCT System Life Spine, Inc. KWP Class II 2015-04-23
K150583 Aequalis PerFORM+ Shoulder System Tornier, Inc. KWS Class II 2015-04-23
K150501 Zimmer Nexel Total Elbow Ulnar Cement Diverter Zimmer, Inc. JDC Class II 2015-04-23
K143363 VENUS Spinal Fixation System L&K BIOMED Co., Ltd. NKB Class II 2015-04-22
K143739 POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA Smith & Nephew, Inc. LZO Class II 2015-04-20

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