The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Butterfly Plate Fixation System.
| Device ID | K014267 |
| 510k Number | K014267 |
| Device Name: | BUTTERFLY PLATE FIXATION SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard Treharne |
| Correspondent | Richard Treharne MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-27 |
| Decision Date | 2002-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00721902224058 | K014267 | 000 |
| 00721902214707 | K014267 | 000 |
| 00721902215261 | K014267 | 000 |
| 00721902215704 | K014267 | 000 |
| 00721902216077 | K014267 | 000 |
| 00721902219535 | K014267 | 000 |
| 00721902221927 | K014267 | 000 |
| 00721902222283 | K014267 | 000 |
| 00721902222962 | K014267 | 000 |
| 00721902214691 | K014267 | 000 |