The following data is part of a premarket notification filed by Sofamor Danek with the FDA for Modification To Zplate-atl Anterior Fixation System.
| Device ID | K991460 |
| 510k Number | K991460 |
| Device Name: | MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard W Treharne |
| Correspondent | Richard W Treharne SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-27 |
| Decision Date | 1999-05-19 |
| Summary: | summary |