Globus Medical, Inc. · Class II · Cleared Nov 6, 2018
| K-number | K181846 |
| Device name | ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical Plate System, XTEND Anterior Cervical Plate System, UNIFY Dynamic Anterior Cervical Plate System, CITADEL Anterior Lumbar Plate System, TRUSS Thoracolumbar Plate System, PLYMOUTH Thoracolumbar Plate System, SP-Fix Spinous Process Fixation Plate, RELIEVE Laminoplasty Fixation System |
| Applicant | Globus Medical, Inc. |
| Product code | KWQ |
| Device class | Class II |
| Decision date | Nov 6, 2018 |
| Decision | Substantially Equivalent |
| Regulation | 888.3060 |
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