The following data is part of a premarket notification filed by Zimmer Biomet Spine, Inc. with the FDA for 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.
| Device ID | K202309 |
| 510k Number | K202309 |
| Device Name: | 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 |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Zimmer Biomet Spine, Inc. 10225 Westmoor Drive Westminster, CO 80021 |
| Contact | David Pollard |
| Correspondent | David Pollard Zimmer Biomet Spine, Inc. 10225 Westmoor Drive Westminster, CO 80021 |
| Product Code | KWQ |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MRW |
| Subsequent Product Code | NQW |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-14 |
| Decision Date | 2020-10-08 |