Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 35
- Latest Decision
- 2020-01-03
Clearances · page 32 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K193359 | SureMAX Family of Cervical Spacers | Additive Implants, Inc. | ODP | Class II | 2020-01-03 |
| K191056 | Conformity stem, cemented | United Orthopedic Corporation | JDI | Class II | 2020-01-03 |
| K193092 | TunneLoc Tibial Fixation Device | Biomet, Inc. | MBI | Class II | 2020-01-02 |
| K192578 | InCore TMT System | Nextremity Solutions, Inc. | HWC | Class II | 2019-12-31 |
| K193050 | Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem | Zimmer GmbH | LZO | Class II | 2019-12-26 |
| K192768 | Temporary Fixation Pins | Eisertech, LLC | JDW | Class II | 2019-12-26 |
| K191960 | Arthrex Univers Revers Modular Glenoid System | Arthrex, Inc. | PHX | Class II | 2019-12-23 |
| K192645 | Trigon Ti Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | PLF | Class II | 2019-12-23 |
| K182718 | Mini and Micro Fragments Reconstruction System GMReis | Gm Dos Reis Industria E Comerico Ltda. | HRS | Class II | 2019-12-23 |
| K192559 | Acetabular Bone Screws (for MobileLink Acetabular Cup System) | Waldemar Link GmbH & Co. KG | LZO | Class II | 2019-12-21 |
| K190633 | NanoOrtho NanoKnee® System | Nanoortho, LLC | HRY | Class II | 2019-12-20 |
| K192873 | SX-One MicroKnife | Sonex Health, Inc. | LXH | Class I | 2019-12-20 |
| K190284 | Bengal Stackable Cage System | Medos International SARL | PLR | Class II | 2019-12-20 |
| K192718 | Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | MAX | Class II | 2019-12-20 |
| K192044 | 4CIS Marlin PEEK ACIF Cage | Solco Biomedical Co., Ltd. | ODP | Class II | 2019-12-19 |
| K192189 | Avenir Complete Hip System, Size 0 Coxa Vara | Zimmer, Inc. | LZO | Class II | 2019-12-18 |
| K192680 | Percusys® Plus Pedicle Screw System | Joimax GmbH | NKB | Class II | 2019-12-18 |
| K193219 | G Surgical Marksman System | G Surgical, LLC | NKB | Class II | 2019-12-17 |
| K192450 | Precision Casting Solutions Total Hip System | Precision Casting Solution, LLC | LPH | Class II | 2019-12-17 |
| K193174 | Keos Lumbar IBFD | Keos | MAX | Class II | 2019-12-16 |
| K181548 | Pantheon Spinal Pontus Interbody Fusion Device | Pantheon Spinal | MAX | Class II | 2019-12-16 |
| K191834 | Stand-Alone ALIF Titanium System | Life Spine, Inc. | OVD | Class II | 2019-12-16 |
| K192356 | Airlock Centrolock Osteosynthesis Implant System | Novastep | HRS | Class II | 2019-12-14 |
| K190738 | MyShoulder Placement Guides | Medacta International S.A. | PHX | Class II | 2019-12-13 |
| K191118 | Avanti Distal Radius and Forearm System | Avanti Orthopaedics, Inc. | HRS | Class II | 2019-12-13 |
| K191796 | Neo Cage System | Neo Medical SA | MAX | Class II | 2019-12-13 |
| K193157 | Arthrex 3.9mm Corkscrew Suture Anchor | Arthrex, Inc. | MAI | Class II | 2019-12-12 |
| K192938 | Invictus Spinal Fixation System | Alphatec Spine, Inc. | NKB | Class II | 2019-12-12 |
| K182987 | Genesys Spine 3DP Lumbar Interbody System | Genesys Spine | MAX | Class II | 2019-12-12 |
| K192507 | LOSPA II Knee System | Corentec Co., Ltd. | JWH | Class II | 2019-12-11 |
| K191793 | Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System | Nebula Surgical Private Limited | HRS | Class II | 2019-12-09 |
| K190656 | Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings | Zimmer, Inc. | LPH | Class II | 2019-12-06 |
| K193030 | Avenir Muller Stem, Avenir Cemented Hip Stem | Zimmer GmbH | LZO | Class II | 2019-12-06 |
| K191996 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | HSX | Class II | 2019-12-05 |
| K190660 | G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System Vivacit-E Vitamin E Highly Crosslinked Polyethylene | Zimmer, Inc. | LPH | Class II | 2019-12-05 |
| K192335 | TRACKER Kyphoplasty System | GS Medical Co., Ltd. | NDN | Class II | 2019-12-04 |
| K192132 | SeaSpine Beachside System | SeaSpine Orthopedics Corporation | MAX | Class II | 2019-12-03 |
| K192473 | Exsomed Wrist Plating System | Exsomed Corporation | HRS | Class II | 2019-12-03 |
| K193083 | M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System | Medacta International S.A. | OUR | Class II | 2019-12-03 |
| K192394 | Hi-Fatigue Bone Cement | Osartis GmbH | LOD | Class II | 2019-12-02 |
| K190588 | Integra TITAN Reverse Shoulder System | Integra LifeSciences Corporation | PHX | Class II | 2019-12-02 |
| K193040 | Resorbable Mesh Device | SeaSpine Orthopedics Corporation | MQV | Class II | 2019-11-30 |
| K192365 | Shoulder Innovations Total Shoulder System | Shoulder Innovations, Inc. | KWT | Class II | 2019-11-29 |
| K192379 | Hi-Fatigue G Bone Cement | Osartis GmbH | LOD | Class II | 2019-11-27 |
| K190577 | World Knee Total Knee Systems | Signature Orthopaedics Pty, Ltd. | JWH | Class II | 2019-11-27 |
| K192026 | Peridot Intervertebral body fusion System | Gbs Commonwealth Co., Ltd. | MAX | Class II | 2019-11-26 |
| K192396 | Streamline MIS Spinal Fixation System | Pioneer Surgical Technology, Inc. | NKB | Class II | 2019-11-26 |
| K192946 | DePuy Corail AMT Hip Prosthesis | DePuy Orthopaedics, Inc. | LZO | Class II | 2019-11-26 |
| K192417 | ARIX Cannulated Screw System | Jeil Medical Corporation | HWC | Class II | 2019-11-26 |
| K191426 | FiberTak Button | Arthrex, Inc. | MBI | Class II | 2019-11-26 |
| K190911 | Physica KR Liner and SMR Reverse Humeral Liner | Limacorporate | JWH | Class II | 2019-11-26 |
| K192919 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | LPH | Class II | 2019-11-26 |
| K192745 | DePuy Synthes Trauma Screws | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | HWC | Class II | 2019-11-26 |
| K192248 | Cortina [MAX] Lumbar Cage System | Neurostructures, Inc. | MAX | Class II | 2019-11-25 |
| K192964 | Parcus Synd-EZ SS | Parcus Medical, LLC | MBI | Class II | 2019-11-22 |
| K192126 | AMIStem-P Short Neck | Medacta International S.A. | LZO | Class II | 2019-11-22 |
| K191746 | SMR TT Augmented Glenoid System | Lima Corporate S.P.A. | PHX | Class II | 2019-11-22 |
| K192675 | VariAx Foot | Stryker GmbH | HRS | Class II | 2019-11-22 |
| K190439 | Engage Partial Knee System | Engage Uni, LLC | NJD | Class II | 2019-11-21 |
| K192592 | Axis Plating System | Extremity Medical, LLC | HRS | Class II | 2019-11-21 |
| K192792 | TranS1 AxiaLIF Plus System | Trans1 | KWQ | Class II | 2019-11-20 |
| K192323 | PolyLock Small Bone Plating System | Fusion Orthopedics, LLC | HRS | Class II | 2019-11-18 |
| K191247 | SmartSPACE Shoulder System | Techmah Medical, LLC | KWS | Class II | 2019-11-15 |
| K190391 | TDM Plate and Screw Systems | Tdm Co., Ltd. | HRS | Class II | 2019-11-15 |
| K183666 | EBA One Nailing System | Citieffe S.R.L. | HSB | Class II | 2019-11-14 |
| K190721 | LongBow Ti | Life Spine, Inc. | MAX | Class II | 2019-11-14 |
| K192582 | NuVasive CoRoent Small Interlock System | Nu Vasive, Incorporated | OVE | Class II | 2019-11-13 |
| K191477 | AEON-C Stand Alone System | Huvexel Co. , Ltd. | OVE | Class II | 2019-11-13 |
| K192915 | GMA 2.0 Pedicle Screw System | Grafton Medical Alliance | NKB | Class II | 2019-11-13 |
| K191972 | ARIX Wrist System | Jeil Medical Corporation | HRS | Class II | 2019-11-12 |
| K192049 | Oryx Cervical Plate System | Innovasis, Inc. | KWQ | Class II | 2019-11-08 |
| K192297 | APTUS Wrist Arthrodesis Plates | Medartis AG | HRS | Class II | 2019-11-08 |
| K182301 | PFC SIGMA Knee System | DePuy Orthopaedics, Inc. | JWH | Class II | 2019-11-08 |
| K192403 | VK100 Percutaneous Vertebral Augmentation System | Bonwrx, Ltd. | NDN | Class II | 2019-11-08 |
| K192181 | PRECICE Plating System | Nuvasive Specialized Orthopedics, Inc. | KTT | Class II | 2019-11-07 |
| K192327 | DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile | Synthes (USA) Products, LLC | HRS | Class II | 2019-11-07 |
| K191651 | Arthrex Nano SwiveLock Suture Anchor | Arthrex, Inc. | HWC | Class II | 2019-11-06 |
| K192198 | Conformis Hip System | Conformis, Inc. | LPH | Class II | 2019-11-06 |
| K183457 | Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head | Zimmer, Inc. | LPH | Class II | 2019-11-05 |
| K191047 | ADI TiDAL Osteotomy Wedge | Additive Device, Inc. (Adi) D/B/A Restor3D | PLF | Class II | 2019-11-05 |
| K192236 | Fitmore Hip Stem | Zimmer GmbH | KWY | Class II | 2019-11-05 |
| K192168 | Idys ALIF ZP 3DTi | Clariance, Sas | OVD | Class II | 2019-11-04 |
| K190143 | LARS AC Band Device | Corin USA | HTN | Class II | 2019-11-04 |
| K191974 | NuVasive AttraX Putty | Nu Vasive, Incorporated | MQV | Class II | 2019-11-03 |
| K192824 | Parcus Knotless AP Suture Anchors | Parcus Medical, LLC | MAI | Class II | 2019-11-02 |
| K191622 | Delta Multihole TT Pro Acetabular System | Lima Corporate S.P.A. | LPH | Class II | 2019-11-01 |
| K190344 | DePuy Corail AMT Hip Prosthesis | Depuy(Ireland) | LZO | Class II | 2019-11-01 |
| K191016 | COPAL exchange G Hip and Knee Spacers | Heraeus Medical GmbH | KWY | Class II | 2019-11-01 |
| K190544 | XIHPOS ZFUZE Interbody Fusion System | Difusion Technologies | MAX | Class II | 2019-11-01 |
| K192117 | Small VBR | Ulrich GmbH & Co. KG | MQP | Class II | 2019-11-01 |
| K191002 | OR3O Dual Mobility System | Smith & Nephew, Inc. | LPH | Class II | 2019-10-31 |
| K191134 | IB3D ALIF | Medicrea International SA | MAX | Class II | 2019-10-30 |
| K192504 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | HRS | Class II | 2019-10-30 |
| K190921 | Arthrex Low Profile Screws | Arthrex, Inc. | HWC | Class II | 2019-10-30 |
| K192494 | NexGen Anterior Cervical Plate System | Precision Spine | KWQ | Class II | 2019-10-29 |
| K192121 | Black Diamond Pedicle Screw System | Osseus Fusion Systems | NKB | Class II | 2019-10-29 |
| K192041 | G21 SpaceFlex Hip | G21, S.R.L. | MBB | Class II | 2019-10-29 |
| K180347 | 3d Cage | Fims Co., Ltd. | MAX | Class II | 2019-10-28 |
| K190847 | REDAPT Blade Augments | Smith & Nephew, Inc. | LPH | Class II | 2019-10-25 |
| K190181 | Instruments for LINK MEGASYSTEM-C Family | LinkBio Corp. | KRO | Class II | 2019-10-25 |
17,115 clearances in the Orthopedic panel. Data: openFDA.