Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 39
- Latest Decision
- 2020-10-09
Clearances · page 28 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K192921 | Zeos Aqua Vision Pump and tube | Hemodia Sas | HRX | Class II | 2020-10-09 |
| K200793 | LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System | L&K BIOMED Co., Ltd. | NKG | Class II | 2020-10-08 |
| K202309 | Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion System | Zimmer Biomet Spine, Inc. | KWQ | Class II | 2020-10-08 |
| K201939 | GAIA Lumbar Interbody Fusion Device (LIFD) Family | Printerprezz | MAX | Class II | 2020-10-08 |
| K201917 | Piccolo Composite Proximal Tibia Plate System | CarboFix Orthopedics , Ltd. | HRS | Class II | 2020-10-08 |
| K192949 | Flower Suture Anchor Set | Flower Orthopedics Corporation | MBI | Class II | 2020-10-07 |
| K200725 | Citregen Tendon Interference Screw and Citrelock | Acuitive Technologies | MAI | Class II | 2020-10-07 |
| K201453 | Fortilink Cages with TiPlus Technology | Paradigm Spine GmbH | MAX | Class II | 2020-10-07 |
| K201701 | R3 HA Coated Acetabular Shells | Smith & Nephew, Inc. | MBL | Class II | 2020-10-06 |
| K200953 | NuVasive® Cohere® Thoracolumbar Interbody System | Nu Vasive, Incorporated | MAX | Class II | 2020-10-06 |
| K200728 | Pitkar DeftFix System | S.H.Pitkar Orthotools Pvt. , Ltd. | KTT | Class II | 2020-10-06 |
| K200792 | MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides | Medacta Inernational SA | PQC | Class II | 2020-10-05 |
| K201659 | KHEIRON® Spinal Fixation System | S.M.A.I.O | NKB | Class II | 2020-10-05 |
| K202207 | Materialise PKA Guide System | Materialise NV | HSX | Class II | 2020-10-02 |
| K202190 | Oculus-SA Lumbar Cage System | Neurostructures | OVD | Class II | 2020-10-02 |
| K200127 | TELEGRAPH® EVOLUTION Humeral Nailing System | FH Industrie | HSB | Class II | 2020-10-01 |
| K200067 | MectaScope System | Medacta International S.A. | HRX | Class II | 2020-10-01 |
| K201820 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System and Brigade Hyperlordotic System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, 3DP Interfixated ALIF System | Nu Vasive, Incorporated | MAX | Class II | 2020-09-25 |
| K193546 | Distal Centralizers | Biomet, Inc. | JDG | Class II | 2020-09-25 |
| K200115 | Cavetto-SA Cervical Cage System | Neurostructures, Inc. | OVE | Class II | 2020-09-24 |
| K202484 | Cordera Hip System | Conformis, Inc. | LPH | Class II | 2020-09-24 |
| K201367 | FlareHawk TiHawk9 Interbody Fusion System | Integrity Implants, Inc. | MAX | Class II | 2020-09-23 |
| K201346 | DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm | Synthes (USA) Products, LLC | HSB | Class II | 2020-09-23 |
| K202569 | Responsive Arthroscopy Interference Screw System | Responsive Arthroscopy, LLC | HWC | Class II | 2020-09-23 |
| K200987 | LTJ Screws and Washer | Azurmeds, Inc. | HWC | Class II | 2020-09-22 |
| K200123 | Accessories for the SixFix® Hexapod Fixator | Arrowhead De, LLC | KTT | Class II | 2020-09-22 |
| K201278 | World Hip Stem, World Cup, World Liner | Signature Orthopaedics Pty, Ltd. | MEH | Class II | 2020-09-21 |
| K201673 | SMS Cementless Stem | Medacta International S.A. | LZO | Class II | 2020-09-18 |
| K202022 | GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS (Vitamin E Highly Crosslinked UHMWPE) | Medacta International S.A. | JWH | Class II | 2020-09-18 |
| DEN200010 | Spineology Interbody Fusion System | Spineology, Inc. | OQB | Class II | 2020-09-18 |
| K202399 | OrthoButton FL | Riverpoint Medical | MBI | Class II | 2020-09-18 |
| K201538 | Life Spine SIMPACT Sacroiliac Joint Fixation System | Life Spine, Inc. | OUR | Class II | 2020-09-18 |
| K201073 | Seaspine WaveForm C Interbody System | SeaSpine Orthopedics Corporation | OVE | Class II | 2020-09-18 |
| K193368 | Smart Correction System | Wishbone Medical, Inc. | KTT | Class II | 2020-09-18 |
| K202192 | STRUXXURE®-L and STRUXXURE®-A Plate System | Nexxt Spine, LLC | KWQ | Class II | 2020-09-17 |
| K200430 | Precice® Ankle Salvage System | Nuvasive Specialized Orthopedics, Inc. | HSB | Class II | 2020-09-16 |
| K201664 | FIREBIRD SI Fusion System | Orthofix, Inc. | OUR | Class II | 2020-09-15 |
| K201656 | ARIX Elbow System | Jeil Medical Corporation | HRS | Class II | 2020-09-15 |
| K202227 | Artus cervical plate system | Ulrich GmbH & Co. KG | KWQ | Class II | 2020-09-14 |
| K200343 | FusionFrame Ring Lock System | Glw Medical Innovation | KTT | Class II | 2020-09-14 |
| K201646 | Shoreline ACS (Anterior Cervical System) | SeaSpine Orthopedics Corporation | OVE | Class II | 2020-09-14 |
| K200854 | DePuy PINNACLE Dual Mobility Liner | Depuy Ireland UC | LPH | Class II | 2020-09-11 |
| K201506 | Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System | Meditech Spine, LLC | ODP | Class II | 2020-09-11 |
| K202143 | Dynex Micro | Vilex, LLC | KTT | Class II | 2020-09-11 |
| K201959 | DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System | DePuy Synthes | HRS | Class II | 2020-09-11 |
| K201315 | PERFORM Humeral System Stem | Tornier, Inc. | PAO | Class II | 2020-09-11 |
| K201145 | X-Pac Expandable Lumbar Cage System | Expanding Innovations, Inc. | MAX | Class II | 2020-09-10 |
| K201407 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | NKB | Class II | 2020-09-10 |
| K202153 | Responsive Arthroscopy Suture Anchor System | Responsive Arthroscopy, LLC | MBI | Class II | 2020-09-09 |
| K201578 | DePuy Synthes Variable Angle Locking Patella Plating System | Synthes (USA) Products, LLC | HRS | Class II | 2020-09-09 |
| K202328 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | NKB | Class II | 2020-09-08 |
| K201721 | TruLift Expandable Spacer System | Life Spine, Inc. | MAX | Class II | 2020-09-04 |
| K201769 | Cavetto [MAX] Cervical Cage System | Neurostructures, Inc. | ODP | Class II | 2020-09-03 |
| K201522 | Arthrex Syndesmosis TightRope XP Buttress Plate Implant System | Arthrex, Inc. | HTN | Class II | 2020-09-03 |
| K201336 | DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm | Synthes (USA) Products, LLC | JDS | Class II | 2020-09-03 |
| K200503 | ATL Anchors | International Life Sciences | MBI | Class II | 2020-09-02 |
| K201677 | Arthrex Mesh Plates | Arthrex, Inc. | HRS | Class II | 2020-09-02 |
| K201831 | CONFIDENCE Spinal Cement System | Depuy Spine, Inc. | NDN | Class II | 2020-08-31 |
| K200958 | MODULIF-A Anterior Lumbar Interbody Fusion System | Spinal Stability, LLC | MAX | Class II | 2020-08-28 |
| K202099 | AOS Galileo Trochanteric Nail System | Advanced Orthopaedic Solutions, Inc. | HSB | Class II | 2020-08-28 |
| K201830 | ANSER Clavicle Pin | BAAT Medical Products B.V. | HSB | Class II | 2020-08-27 |
| K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek | MAX | Class II | 2020-08-26 |
| K192863 | MONDRIAN Lumbar Interbody Fusion Cage System | Ctl Medical Corporation | MAX | Class II | 2020-08-26 |
| K202064 | Admiral ACP System | SeaSpine Orthopedics Corporation | KWQ | Class II | 2020-08-26 |
| K201979 | Cervical Plate System | Eminent Spine, LLC | KWQ | Class II | 2020-08-25 |
| K202054 | Dynex Ring Fixation System, Diametrix Ring Fixation System | Vilex, LLC | KTT | Class II | 2020-08-24 |
| K201749 | Arthrex SwiveLock Anchor | Arthrex, Inc. | MAI | Class II | 2020-08-21 |
| K201636 | Hercules Suture Anchor System | In2bones USA, LLC | MBI | Class II | 2020-08-20 |
| K201362 | CD Horizon Fenestrated Screw Set, CD Horizon Spinal System, Kyphon HV-R Bone Cement | Medtronic | PML | Class II | 2020-08-19 |
| K190600 | ORION Spinal System | Orion Biotech, Inc. | NKB | Class II | 2020-08-18 |
| K200064 | OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft | SurGenTec, LLC | MQV | Class II | 2020-08-14 |
| K191708 | Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head | Signature Orthopaedics Pty, Ltd. | LPH | Class II | 2020-08-14 |
| K193429 | Exeter V40 Femoral Stem, Exeter X3 RimFit Cup | Howmedica Osteonics Corp. | JDI | Class II | 2020-08-13 |
| K201960 | SpaceFlex Knee - 80mm Size | G21, S.R.L. | MBB | Class II | 2020-08-13 |
| K200895 | Univers Revers Modular Glenoid System, Half Augment Baseplate | Arthrex, Inc. | PHX | Class II | 2020-08-13 |
| K201961 | IlluminOss Photodynamic Bone Stabilization System | Illuminoss Medical, Inc. | QAD | Class II | 2020-08-13 |
| K200763 | Osteo-site Vertebral Balloon | Izi Medical | HRX | Class II | 2020-08-12 |
| K193312 | UNIKO PointCloud Knee Instruments | Unik Orthopedics, Inc. | MBH | Class II | 2020-08-12 |
| K193175 | Lateralized Glenosphere | Medacta Inernational SA | PHX | Class II | 2020-08-11 |
| K200981 | Mega Plus MIS Spine System | Bk Meditech, Co., Ltd. | NKB | Class II | 2020-08-11 |
| K200592 | GS Medical AnyPlus PEEK Cage System | GS Medical Co., Ltd. | ODP | Class II | 2020-08-10 |
| K201567 | Precice® Bone Transport System | Nuvasive Specialized Orthopedics, Inc. | HSB | Class II | 2020-08-10 |
| K201585 | Monterey AL Interbody System | Stryker Corporation | OVD | Class II | 2020-08-10 |
| K201926 | CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System | CarboFix Orthopedics , Ltd. | NKB | Class II | 2020-08-07 |
| K201883 | 6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor | Medos International SARL | MBI | Class II | 2020-08-07 |
| K201521 | Medina Anterior Cervical Plate System | Alliance Partners, LLC | KWQ | Class II | 2020-08-06 |
| K190580 | NADIA SI Fusion System | Ilion Medical, Inc. | OUR | Class II | 2020-08-05 |
| K201079 | Aurora® Anterior Lumbar Plate Sytstem | Prism Surgical Design Pty , Ltd. | KWQ | Class II | 2020-08-05 |
| K201240 | Mariner Cap System | SeaSpine Orthopedics Corporation | OWI | Class II | 2020-08-05 |
| K193247 | LATITUDE EV Total Elbow Arthroplasty | Tornier, Inc. | JDB | Class II | 2020-08-05 |
| K201715 | Smart Toe II, X Fuse | Stryker GmbH | HTY | Class II | 2020-08-05 |
| K192883 | Spartan Hip Stem | Signature Orthopaedics Pty, Ltd. | LZO | Class II | 2020-08-05 |
| K201500 | Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar Spacer | Life Spine, Inc. | MAX | Class II | 2020-08-04 |
| K201704 | CoFix System | Paradigm Spine GmbH | PEK | Class II | 2020-08-04 |
| K201850 | Vector Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | HWC | Class II | 2020-08-04 |
| K191670 | CureOs TCP | Linacol Muh Dan Kim Cev Tek Med Ith Ihr San VE Tic | MQV | Class II | 2020-08-04 |
| K193545 | Corin Optimized Positioning System (OPS) Femoral | Corin USA | LZO | Class II | 2020-08-04 |
| K201087 | CORBEL Spacers | Globus Medical, Inc. | OVD | Class II | 2020-07-31 |
| K201951 | Cemented Origin Hip Stem | Signature Orthopaedics Pty, Ltd. | LZO | Class II | 2020-07-31 |
| K201851 | EXULT Femoral component trial - Left, EXULT Femoral component trial - Right | Corentec Co., Ltd. | JWH | Class II | 2020-07-30 |
17,115 clearances in the Orthopedic panel. Data: openFDA.