The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Centerpiece Plate Fixation System.
| Device ID | K050082 |
| 510k Number | K050082 |
| Device Name: | CENTERPIECE PLATE FIXATION SYSTEM |
| Classification | Orthosis, Spine, Plate, Laminoplasty, Metal |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard W Treharne, Phd. |
| Correspondent | Richard W Treharne, Phd. MEDTRONIC SOFAMOR DANEK, INC. 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 | 2005-01-13 |
| Decision Date | 2005-06-06 |
| Summary: | summary |