The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Centerpiece Plate Fixation System.
| Device ID | K212428 |
| 510k Number | K212428 |
| Device Name: | Centerpiece Plate Fixation System |
| Classification | Orthosis, Spine, Plate, Laminoplasty, Metal |
| Applicant | Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132 |
| Contact | Diamond Wallace |
| Correspondent | Diamond Wallace Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132 |
| Product Code | NQW |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-04 |
| Decision Date | 2021-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000553524 | K212428 | 000 |
| 00763000552190 | K212428 | 000 |
| 00763000552206 | K212428 | 000 |
| 00763000552213 | K212428 | 000 |
| 00763000552220 | K212428 | 000 |
| 00763000552237 | K212428 | 000 |
| 00763000552244 | K212428 | 000 |
| 00763000552251 | K212428 | 000 |
| 00763000553456 | K212428 | 000 |
| 00763000553463 | K212428 | 000 |
| 00763000553470 | K212428 | 000 |
| 00763000553487 | K212428 | 000 |
| 00763000553494 | K212428 | 000 |
| 00763000553500 | K212428 | 000 |
| 00763000553517 | K212428 | 000 |
| 00763000552183 | K212428 | 000 |