The following data is part of a premarket notification filed by Danek Medical, Inc. with the FDA for Atlantis Anterior Cervical Plate System.
| Device ID | K993855 |
| 510k Number | K993855 |
| Device Name: | ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | DANEK MEDICAL, INC. 1800 PYRAMID PL. Memphis, TN 38132 |
| Contact | Richard W Treharne |
| Correspondent | Richard W Treharne DANEK MEDICAL, INC. 1800 PYRAMID PL. Memphis, TN 38132 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-15 |
| Decision Date | 1999-12-15 |
| Summary: | summary |