The following data is part of a premarket notification filed by Sofamor Danek Mfg., Inc. with the FDA for Z-plate Anterior Fixation System.
| Device ID | K922543 |
| 510k Number | K922543 |
| Device Name: | Z-PLATE ANTERIOR FIXATION SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SOFAMOR DANEK MFG., INC. 3092 DIRECTORS ROW Memphis, TN 38131 |
| Contact | Richard W Treharne |
| Correspondent | Richard W Treharne 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 | 1992-05-29 |
| Decision Date | 1993-05-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00673978948379 | K922543 | 000 |
| 00673978928449 | K922543 | 000 |