The following data is part of a premarket notification filed by Sofamor Danek Mfg., Inc. with the FDA for Tsrh Central Post Hooks.
| Device ID | K925811 |
| 510k Number | K925811 |
| Device Name: | TSRH CENTRAL POST HOOKS |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| 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 | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-06 |
| Decision Date | 1993-05-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00673978040400 | K925811 | 000 |
| 00721902782640 | K925811 | 000 |
| 00673978039527 | K925811 | 000 |
| 00673978039565 | K925811 | 000 |
| 00673978039848 | K925811 | 000 |
| 00673978039923 | K925811 | 000 |
| 00673978039954 | K925811 | 000 |
| 00673978039985 | K925811 | 000 |
| 00673978040141 | K925811 | 000 |
| 00673978040158 | K925811 | 000 |
| 00673978040165 | K925811 | 000 |
| 00673978040172 | K925811 | 000 |
| 00673978040356 | K925811 | 000 |
| 00673978040363 | K925811 | 000 |
| 00673978040370 | K925811 | 000 |
| 00673978040387 | K925811 | 000 |
| 00673978040394 | K925811 | 000 |
| 00721902782633 | K925811 | 000 |