The following data is part of a premarket notification filed by Sofamor Danek Mfg., Inc. with the FDA for Tsrh Spinal Screws.
| Device ID | K932029 |
| 510k Number | K932029 |
| Device Name: | TSRH SPINAL SCREWS |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| 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 | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-27 |
| Decision Date | 1995-01-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00673978040332 | K932029 | 000 |
| 00673978036281 | K932029 | 000 |
| 00673978036298 | K932029 | 000 |
| 00673978036304 | K932029 | 000 |
| 00673978036311 | K932029 | 000 |
| 00673978036328 | K932029 | 000 |
| 00673978036434 | K932029 | 000 |
| 00673978036441 | K932029 | 000 |
| 00673978036458 | K932029 | 000 |
| 00673978040325 | K932029 | 000 |
| 00673978036274 | K932029 | 000 |