The following data is part of a premarket notification filed by Sofamor Danek Mfg., Inc. with the FDA for Sterile Dyna Lok Anterior Plating System.
| Device ID | K923446 |
| 510k Number | K923446 |
| Device Name: | STERILE DYNA LOK ANTERIOR PLATING SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SOFAMOR DANEK MFG., INC. 3092 DIRECTORS ROW Memphis, TN 38131 |
| Contact | Bailey Lipscomb |
| Correspondent | Bailey Lipscomb SOFAMOR DANEK MFG., INC. 3092 DIRECTORS ROW Memphis, TN 38131 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-14 |
| Decision Date | 1992-12-17 |