Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 34
- Latest Decision
- 2019-06-19
Clearances · page 35 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K190889 | Republic Spine Restore Cervical Interbody Fusion System | Republic Spine, LLC | ODP | Class II | 2019-06-19 |
| K182785 | LOQTEQ VA Foot Plates 2.5 | Aap Implantate AG | HRS | Class II | 2019-06-19 |
| K190684 | LxHA PEEK Lateral IBF System | Innovasis, Inc. | MAX | Class II | 2019-06-17 |
| K191318 | AEQUALIS FLEX REVIVE Shoulder System | Tornier, Inc. | KWS | Class II | 2019-06-14 |
| K182608 | Oyster ACIF Cage | Silony Medical GmbH | ODP | Class II | 2019-06-13 |
| K183363 | Treace Medical Concepts (TMC) Snap-Off Screw System | Treace Medical Concepts, Inc. | HWC | Class II | 2019-06-13 |
| K191005 | ProLift® Expandable System | Life Spine, Inc. | MAX | Class II | 2019-06-13 |
| K190521 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | KWS | Class II | 2019-06-12 |
| K190016 | Lateral Plate System | Corelink, LLC | KWQ | Class II | 2019-06-12 |
| K191226 | Arthrex SwiveLock Suture Anchor | Arthrex, Inc. | MAI | Class II | 2019-06-11 |
| K182416 | NOVA Minimally Invasive System | Baui Biotech Co., Ltd. | NKB | Class II | 2019-06-11 |
| K191271 | T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System | Stryker Trauma GmbH | HSB | Class II | 2019-06-11 |
| K190814 | AccuFill Bone Substitute Material | Zimmer Knee Creations | MQV | Class II | 2019-06-10 |
| K183104 | Mini Cannulated Headed and Headless Screw Set | Stryker GmbH | HWC | Class II | 2019-06-10 |
| K182650 | Arzzt Distal Radius and Ulna System | Truemed Group, LLC | HRS | Class II | 2019-06-10 |
| K190216 | SpaceFlex Knee | G21, S.R.L. | MBB | Class II | 2019-06-09 |
| K190057 | DJO Acetabular System | Encore Medical L.P. | LPH | Class II | 2019-06-07 |
| K190388 | RIVAL View Plating Systems and Reduce Fracture Plating Systems | Orthofix Srl | HRS | Class II | 2019-06-07 |
| K191263 | Idys ALIF TiVac | Clariance, Sas | OVD | Class II | 2019-06-06 |
| K183620 | PROSTEP TBC Implant System | Wrightmedicaltechnologyinc | HRS | Class II | 2019-06-06 |
| K190618 | RIGEL PEEK Anterior Cervical Interbody Fusion System | MiRus, LLC | ODP | Class II | 2019-06-06 |
| K183114 | Corin BiPolar-i | Corin U.S.A. Limited | KWY | Class II | 2019-06-05 |
| K190595 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | KWT | Class II | 2019-06-05 |
| K190804 | HydroCision TenJet Device | Hydrocision, Inc. | HRX | Class II | 2019-06-05 |
| K190068 | Vanguard XP Knee System | Zimmer, Inc. | JWH | Class II | 2019-06-04 |
| K190892 | MectaScrew PEEK Interference Screw | Medacta International S.A. | MBI | Class II | 2019-06-04 |
| K183533 | Unity Total Knee System | Corin U.S.A. Limited | JWH | Class II | 2019-06-04 |
| K191185 | Solanas® Posterior OCT Fixation System | Alphatec Spine | NKG | Class II | 2019-06-03 |
| K190766 | PALACOS fast R+G | Heraeus Medical GmbH | LOD | Class II | 2019-05-31 |
| K190546 | NEXXT MATRIXX Stand Alone Cervical System | Nexxt Spine, LLC | OVE | Class II | 2019-05-31 |
| K190543 | Cannulated Hemi Implant | Vilex IN Tennessee, Inc. | KWD | Class II | 2019-05-31 |
| K182678 | Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling | Zimmer, Inc. | LPH | Class II | 2019-05-31 |
| K190565 | Cervical Plate | Eisertech, LLC | KWQ | Class II | 2019-05-31 |
| K191145 | MasterLoc Extension | Medacta International S.A. | LZO | Class II | 2019-05-30 |
| K183084 | Fuji Cervical Plate System | Altus Partners, LLC | KWQ | Class II | 2019-05-29 |
| K181630 | Revolution External Plating System | New Standard Device Dba Metalogix | KTT | Class II | 2019-05-29 |
| K190877 | Juliet® Ti LL Lumbar Interbody Device | Spineart | OVD | Class II | 2019-05-29 |
| K190474 | MectaLock PEEK Suture Anchor | Medacta International S.A. | MBI | Class II | 2019-05-28 |
| K182544 | AccelFix Spinal Fixation System | L&K BIOMED Co., Ltd. | NKB | Class II | 2019-05-28 |
| K190482 | IGNITE Bone Void Filler | Wrightmedicaltechnologyinc | MQV | Class II | 2019-05-28 |
| K182321 | MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | LZO | Class II | 2019-05-24 |
| K190231 | InCore® Lapidus Sterile Kits | Nextremity Solutions, Inc. | HWC | Class II | 2019-05-24 |
| K183560 | Luna 3D GEN2 Interbody Fusion System | Benvenue Medical, Inc. | MAX | Class II | 2019-05-23 |
| K183054 | SYNMESH System | Depuy Synthes Spine | MQP | Class II | 2019-05-23 |
| K183639 | Mariner Outrigger Revision System | SeaSpine Orthopedics Corporation | NKB | Class II | 2019-05-23 |
| K191091 | Rampart One Lumbar Interbody Fusion System | Spineology, Inc. | OVD | Class II | 2019-05-23 |
| K190751 | Connector System | Orthofix, Inc. | NKG | Class II | 2019-05-22 |
| K182342 | IntraLock Lapidus System | Fusion Orthopedics, LLC | HWC | Class II | 2019-05-21 |
| K190125 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire | T.A.G. Medical Products Corporation, Ltd. | MBI | Class II | 2019-05-19 |
| K183077 | Delta Xtend Reverse Shoulder System | Depuy(Ireland) | PHX | Class II | 2019-05-17 |
| K183618 | Revolution Radial Head | Ignite Orthopedics, Inc. | KWI | Class II | 2019-05-17 |
| K190355 | Precision Casting Solutions Total Knee System | Precision Casting Solutions, Inc. | JWH | Class II | 2019-05-16 |
| K182251 | EVOLUTION NitrX Medial-Pivot Knee | Mircoport Orthopedics, Inc. | JWH | Class II | 2019-05-16 |
| K190584 | CAYMAN LP Plate System | K2m, Inc. | KWQ | Class II | 2019-05-15 |
| K190670 | ORTHOLOC 2 Lapidus with Rotation System | Wrightmedicaltechnologyinc | HRS | Class II | 2019-05-14 |
| K190069 | SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS) | Arrowhead De, LLC | KTT | Class II | 2019-05-14 |
| K190170 | MVP Cervical Plate System | GS Medical Co., Ltd. | KWQ | Class II | 2019-05-13 |
| K183583 | Vanguard Complete Knee System | Zimmer, Inc. | JWH | Class II | 2019-05-10 |
| K190666 | CYGNUS Anterior Cervical Plate System | MiRus, LLC | KWQ | Class II | 2019-05-09 |
| K181491 | Delta Dual Mobility System | Lima Corporate S.P.A. | LZO | Class II | 2019-05-09 |
| K190147 | COLOSSEUM Mesh | Globus Medical, Inc. | MQP | Class II | 2019-05-08 |
| K190567 | KeYi Spinal Fixation System | Beijing Keyi Medical Device Technology Co., Ltd. | NKB | Class II | 2019-05-08 |
| K190092 | UNiD Patient specific 3D printed TLIF cage | Medicrea International SA | MAX | Class II | 2019-05-08 |
| K190165 | Capstone Control Spinal System | Medtronic Sofamor Danek USA, Inc. | MAX | Class II | 2019-05-06 |
| K190287 | Arthrex DynaNite® PIP (Hammertoe) Implant | Arthrex, Inc. | HTY | Class II | 2019-05-03 |
| K190409 | MatrixRIB Fixation System | DePuy Synthes | HRS | Class II | 2019-05-03 |
| K182877 | HALF DOME Posterior Lumbar Interbody System | Astura Medical, LLC | MAX | Class II | 2019-05-03 |
| K190599 | Aptis Medical Distal Radio Ulnar Joint Implant | Aptis Medical, LLC | KXE | Class II | 2019-05-03 |
| K190376 | PASS LP Spinal System | Medicrea International SA | NKB | Class II | 2019-05-02 |
| K190227 | Boomerang Anterior Cervical Plate System | Choicespine, LP | KWQ | Class II | 2019-05-01 |
| K183342 | SambaScrew 3D SI Fusion System | Orthofix, Inc. | OUR | Class II | 2019-04-30 |
| K190655 | SeaSpine® Shoreline ACS- Anterior Cervical Standalone System | SeaSpine Orthopedics Corporation | OVE | Class II | 2019-04-29 |
| K181732 | InterSpace Knee Extra-Large Size, InterSpace Knee ATS | Tecres S.P.A. | JWH | Class II | 2019-04-27 |
| K183094 | CyclaPlex Correction System | Cycla Orthopedics, Ltd. | HTN | Class II | 2019-04-26 |
| K190290 | AltiVate Reverse Humeral Stem, 48mm | Encore Medical L.P. | KWS | Class II | 2019-04-26 |
| K190375 | Parcus ATLAS | Parcus Medical, LLC | MBI | Class II | 2019-04-24 |
| K190110 | NanoBone SBX PUTTY, NanoBone QD | Artoss GmbH | MQV | Class II | 2019-04-23 |
| K182516 | Comprehensive Nano Stemless Shoulder | Biomet Manufacturing Corp | PKC | Class II | 2019-04-22 |
| K190415 | ATLAS Plating System | MiRus, LLC | HRS | Class II | 2019-04-19 |
| K183056 | ASSURE® Anterior Cervical Plate System | Globus Medical, Inc. | KWQ | Class II | 2019-04-19 |
| K190364 | CancelleX Porous Titanium Lumbar Interbody Device | Xenco Medical, LLC | MAX | Class II | 2019-04-18 |
| K183395 | Arthrex 2.5 mm Tenodesis Screw | Arthrex, Inc. | HWC | Class II | 2019-04-17 |
| K190728 | Arthrex SwiveLock Anchors | Arthrex, Inc. | MBI | Class II | 2019-04-17 |
| K190658 | MIS Bunion Plating System | Crossroads Extremity Systems, LLC | HRS | Class II | 2019-04-12 |
| K190365 | Baby Gorilla/Gorilla Plating System | Paragon 28, Inc. | HRS | Class II | 2019-04-12 |
| K190317 | Zavation Spinal System | Zavation Medical Products, LLC | NKB | Class II | 2019-04-11 |
| K181296 | Syntec Femoral Nail System | Syntec Scientific Corporation | HSB | Class II | 2019-04-11 |
| K190631 | M.U.S.T. MINI Posterior Cervical Screws System | Medacta International S.A. | NKG | Class II | 2019-04-10 |
| K182375 | CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS® | Globus Medical, Inc. | NKB | Class II | 2019-04-08 |
| K183682 | OIC External Fixation System | Orthopaedic Implant Company | KTT | Class II | 2019-04-08 |
| K183550 | Vitality® Spinal Fixation System | Zimmer Biomet Spine, Inc. | NKB | Class II | 2019-04-08 |
| K182287 | MEDINAUT Plus | Imedicom Co., Ltd. | HRX | Class II | 2019-04-06 |
| K190598 | CROSSWAY Spinal Access System | Globus Medical, Inc. | HRX | Class II | 2019-04-05 |
| K183197 | PYRAMESH Implant System | Medtronic Sofamor Danek USA, Inc. | MQP | Class II | 2019-04-04 |
| K182943 | VERTEX Nitinol Staple System | Nvision Biomedical Technologies, LLC | JDR | Class II | 2019-04-04 |
| K182349 | CONCORDE LIFT | Medos International SARL | MAX | Class II | 2019-04-03 |
| K183184 | FlareHawk Interbody Fusion System | Integrity Implants, Inc. | MAX | Class II | 2019-04-03 |
| K190586 | Monster® Screw System | Paragon 28, Inc. | HWC | Class II | 2019-04-03 |
| K182872 | LINK GEMINI SL Total Knee System | Waldemar Link GmbH & Co. KG | JWH | Class II | 2019-04-03 |
| K190289 | Karma® Fixation System | Spinal Elements, Inc. | OWI | Class II | 2019-04-03 |
17,115 clearances in the Orthopedic panel. Data: openFDA.