Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 31
- Latest Decision
- 2016-08-25
Clearances · page 50 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | MAX | Class II | 2016-08-25 |
| K161516 | G Surgical Marksman MIS System | G Surgical, LLC | NKB | Class II | 2016-08-25 |
| K161189 | Integra TITAN Reverse Shoulder System | Integra LifeSciences Corporation | PHX | Class II | 2016-08-25 |
| K160983 | Kyphon HV-R Bone Cement | Medtronic, Inc. | NDN | Class II | 2016-08-24 |
| K160646 | XYcor® Expandable Spinal Spacer System | Alphatec Spine, Inc. | MAX | Class II | 2016-08-24 |
| K160702 | ZION Anterior Cervical Fixation System | Astura Medical | KWQ | Class II | 2016-08-23 |
| K160011 | H-Max S stem | Lima Corporate S.P.A. | MEH | Class II | 2016-08-22 |
| K161498 | Streamline OCT Occipito-Cervico-Thoracic System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | NKG | Class II | 2016-08-22 |
| K151458 | Double Medical Universal Spine System | Double Medical Technology, Inc. | MNI | Class II | 2016-08-22 |
| K161766 | PathLoc-L MIS Spinal System | L&K BIOMED Co., Ltd. | NKB | Class II | 2016-08-22 |
| K161405 | Valeo II Interbody Fusion Device System | Amedica Corp. | MAX | Class II | 2016-08-19 |
| K152289 | Alians Elbow Locking Plating System | Newclip Technics | HRS | Class II | 2016-08-17 |
| K161037 | Tarsa-Link Stand-Alone Wedge Fixation System | Life Spine, Inc. | HRS | Class II | 2016-08-15 |
| K161292 | Distal Radius Plating System | Miami Device Solutions, LLC | HRS | Class II | 2016-08-15 |
| K161210 | RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems | Medtronic Sofamor Danek | OUR | Class II | 2016-08-12 |
| K153452 | Salto XT, Salto Talaris | Tornier S.A.S. | HSN | Class II | 2016-08-11 |
| K161267 | Response BandLoc Spinal Fixation | OrthoPediatrics Corp. | OWI | Class II | 2016-08-11 |
| K153573 | Converge | Biomedical Enterprises, Inc. | HRS | Class II | 2016-08-11 |
| K161914 | Genesys Spine TiLock Cortical Spinal System | Genesys Spine | NKB | Class II | 2016-08-09 |
| K161387 | Mont Blanc and Mont Blanc MIS Spinal Systems | Spineway SA | NKB | Class II | 2016-08-04 |
| K161033 | AFX Femoral Implant With Inserter | Cayenne Medical, Inc. | MBI | Class II | 2016-08-03 |
| K161864 | ARIX Foot System | Jeil Medical Corporation | HRS | Class II | 2016-08-02 |
| K161896 | Biomet Microfixation Sternal Closure System | Biomet Microfixation | HRS | Class II | 2016-08-02 |
| K160699 | VIRTU Lumbar Spacer System | Met 1 Technologies, LLC | MAX | Class II | 2016-08-01 |
| K153065 | The Hammertoe Correction System | Life Spine, Inc. | HWC | Class II | 2016-08-01 |
| K153352 | Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System | Spinal Elements, Inc. | OVE | Class II | 2016-08-01 |
| K160856 | SpineView X-Pac Expandable Lumbar Cage System | Spine View, Inc. | MAX | Class II | 2016-08-01 |
| K161627 | PASS LP Spinal System | Medicrea International SA | NKB | Class II | 2016-07-29 |
| K161058 | Cannulated Screw | Miami Device Solutions, LLC | HWC | Class II | 2016-07-29 |
| K153296 | MEDINAUT Kyphoplasty System | Imedicom Co., Ltd. | NDN | Class II | 2016-07-29 |
| K161499 | VertiForm Posterior Fixation System | Next Orthosurgical | NKB | Class II | 2016-07-29 |
| K160465 | Spinal Elements' Spinous Process Plate System | Spinal Elements, Inc. | PEK | Class II | 2016-07-28 |
| K152099 | Genesys Spine Apache® Anchored Cervical Interbody Fusion System | Genesys Spine | OVE | Class II | 2016-07-28 |
| K151424 | The Progressive Orthopaedic Total Hip System | The Progressive Orthopaedic Company, LLC | LPH | Class II | 2016-07-27 |
| K161048 | Conventus Orthopaedics Ulna Fixation System | Conventus Orthopaedics, Inc. | HRS | Class II | 2016-07-26 |
| K160813 | EasyStep | Stryker GmbH | JDR | Class II | 2016-07-26 |
| K161028 | K2M Growing Spine System | K2m, Inc. | PGM | Class II | 2016-07-22 |
| K153439 | PathLoc-C Posterior Cervical Fixation System | L&K BIOMED Co., Ltd. | NKG | Class II | 2016-07-21 |
| K161369 | EVEREST Spinal System | K2m, Incorporated | NKB | Class II | 2016-07-21 |
| K160955 | Tritanium® PL Cage | Stryker | MAX | Class II | 2016-07-21 |
| K160605 | MectaLIF Anterior Stand-Alone | Medacta International | OVD | Class II | 2016-07-21 |
| K161404 | Genesys Spine Apache® Lateral Lumbar Interbody Fusion System | Genesys Spine | MAX | Class II | 2016-07-21 |
| K161155 | Origin Coxa Vara Hip Stem | Signature Orthopaedics Pty, Ltd. | MEH | Class II | 2016-07-19 |
| K160907 | DePuy Actis DuoFix Hip Prosthesis | Depuy(Ireland) | MEH | Class II | 2016-07-19 |
| K160804 | INTRAFIX(TM) Advance Tibial Fastener System | Medos International SARL | MAI | Class II | 2016-07-19 |
| K160631 | Keos Lumbar IBFD | Keos | MAX | Class II | 2016-07-15 |
| K161407 | Ascential IBD PEEKc Spacer | Stryker Spine | ODP | Class II | 2016-07-15 |
| K161265 | NuVasive® VersaTie System | Nu Vasive, Incorporated | OWI | Class II | 2016-07-15 |
| K161223 | TransContinental® M Spacers and InterContinental® Plate-Spacers | Globus Medical, Inc. | OVD | Class II | 2016-07-15 |
| K161694 | Threshold Pedicular Fixation System | Spineology, Inc. | NKB | Class II | 2016-07-15 |
| K153097 | Belvedere Lateral Plating System | Neurostructures, Inc. | KWQ | Class II | 2016-07-15 |
| K161668 | ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) | Conformis, Inc. | JWH | Class II | 2016-07-15 |
| K153621 | Juliet® Ti | Spineart | MAX | Class II | 2016-07-15 |
| K160906 | Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion Device | Spineology, Inc. | MAX | Class II | 2016-07-14 |
| K152511 | Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula | Prosurg, Inc. | HRX | Class II | 2016-07-11 |
| K153786 | PROW FUSION-V | Nlt Spine, Ltd. | MAX | Class II | 2016-07-11 |
| K161149 | PASS OCT Spinal System | Medicrea International SA | NKG | Class II | 2016-07-11 |
| K153105 | MLX - Medial Lateral Expandable Lumbar Interbody System | Nu Vasive, Incorporated | MAX | Class II | 2016-07-11 |
| K160715 | AccuLIF TL and PL Cage | Stryker Corporation | MAX | Class II | 2016-07-08 |
| K152920 | Savannah-T® Pedicle Screw System | Amendia, Inc. | NKB | Class II | 2016-07-08 |
| K161192 | Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System | Zimmer GmbH | LZO | Class II | 2016-07-08 |
| K152622 | Alta ACDF System | Biomet Spine | OVE | Class II | 2016-07-08 |
| K160722 | CorticaLINK Spinal Fusion Platform | Facetlink Dba Linkspine | NKB | Class II | 2016-07-07 |
| K160996 | Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm | Dunamis, LLC | MBI | Class II | 2016-07-06 |
| K160830 | Integra External Fixation System | Ascension Orthopedics | KTT | Class II | 2016-07-06 |
| K160604 | Cure Anterior Cervical Plate (ACP) System | Meditech Spine, LLC | KWQ | Class II | 2016-07-01 |
| K160904 | Expedium Spine System, VIPER and VIPER 2 Systems | Medos International SARL | NKB | Class II | 2016-07-01 |
| K161539 | Arthrosurface Bone Screws | Arthrosurface, Inc. | HWC | Class II | 2016-06-30 |
| K152501 | Spinal Jaxx Interbody Fusion Device | Neuropro Spinaljaxx, Inc. | MAX | Class II | 2016-06-29 |
| K153273 | MySpine Pedicle Screw Placement Guides - LP | Medacta International S.A. | MNI | Class II | 2016-06-29 |
| K160926 | F1 MPS Modular Pedicle Screw System | Degen Medical | NKB | Class II | 2016-06-28 |
| K160874 | Nanovis Intervertebral Body Fusion System and FortiCore® | Nanovis, LLC | MAX | Class II | 2016-06-28 |
| K160697 | Gibralt® Spine System and Gibralt® Occipital Spine System | Exactech, Inc. | NKG | Class II | 2016-06-28 |
| K160916 | CoRoent® Ti-C System | Nu Vasive, Incorporated | MAX | Class II | 2016-06-28 |
| K160820 | PressON Pro Spinal Fixation System | Nexus Spine, LLC | NKB | Class II | 2016-06-28 |
| K161476 | SMR Shoulder System | Lima Corporate S.P.A. | KWT | Class II | 2016-06-24 |
| K153517 | AnyPlus® Cervical PEEK Cage System | GS Medical Co., Ltd. | ODP | Class II | 2016-06-24 |
| K160169 | The Life Spine Subtalar Implant System | Life Spine | HWC | Class II | 2016-06-23 |
| K153057 | FitRite Total Hip Arthroplasty System | Excera Orthopedics, Inc. | JDI | Class II | 2016-06-23 |
| K161280 | Cervical Stand Alone System | Orthofix, Inc. | OVE | Class II | 2016-06-17 |
| K153374 | CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System | Orthocare | HRS | Class II | 2016-06-17 |
| K160071 | StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis | Biomet, Inc. | MBB | Class II | 2016-06-16 |
| K160738 | ZUK Select Knee System | Smith & Nephew, Inc. | HSX | Class II | 2016-06-15 |
| K161366 | ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) | Conformis, Inc. | JWH | Class II | 2016-06-14 |
| K160975 | Aequalis PerFORM+ Shoulder System | Tornier, Inc. | KWS | Class II | 2016-06-10 |
| K161363 | Arsenal Spinal Fixation System | Alphatec Spine, Inc. | NKB | Class II | 2016-06-10 |
| K160995 | NEOVIEW Plating System | In2bones Sas | HRS | Class II | 2016-06-10 |
| K160555 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | KWS | Class II | 2016-06-10 |
| K160700 | ATTUNE Revision Knee System | Depuy(Ireland) | JWH | Class II | 2016-06-10 |
| K160989 | NuVasive® Reline® System | Nu Vasive, Incorporated | NKB | Class II | 2016-06-09 |
| K152011 | Lucent Intervertebral Body Fusion Device | Spinal Elements, Inc. | MAX | Class II | 2016-06-09 |
| K161001 | MILAGRO ADVANCE PEEK Interference Screw | Medos International SARL | MBI | Class II | 2016-06-09 |
| K153436 | LATERAL Spine Truss System | 4Web, Inc. | MAX | Class II | 2016-06-06 |
| K160655 | OrthoButton CL | Riverpoint Medical | MBI | Class II | 2016-06-03 |
| K152893 | Corin Optimized Positioning System (OPS) | Corin USA | LZO | Class II | 2016-06-03 |
| K153131 | Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner | Signature Orthopaedics Pty, Ltd. | MEH | Class II | 2016-06-03 |
| K160652 | iFUSE Implant System | SI-BONE, Inc. | OUR | Class II | 2016-06-03 |
| K160617 | Large Screws Range | Newclip Technics | HWC | Class II | 2016-06-03 |
| K160427 | dynaMX(TM) Nitinol Compression Screw | Mx Orthopedics, Corp. | HWC | Class II | 2016-06-03 |
| K160775 | Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems | Choicespine, LP | NKB | Class II | 2016-06-03 |
17,115 clearances in the Orthopedic panel. Data: openFDA.