The following data is part of a premarket notification filed by Sofamor Danek Usa,inc. with the FDA for Titanium Tsrh(r) Spinal System (screws).
| Device ID | K946348 |
| 510k Number | K946348 |
| Device Name: | TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS) |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | SOFAMOR DANEK USA,INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard W Treharne |
| Correspondent | Richard W Treharne SOFAMOR DANEK USA,INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-30 |
| Decision Date | 1995-08-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00673978042893 | K946348 | 000 |
| 00673978042886 | K946348 | 000 |
| 00673978042879 | K946348 | 000 |
| 00673978042862 | K946348 | 000 |
| 00673978042855 | K946348 | 000 |