The following data is part of a premarket notification filed by Sofamor Danek Usa,inc. with the FDA for Tsrh Spinal System.
| Device ID | K982990 |
| 510k Number | K982990 |
| Device Name: | TSRH SPINAL SYSTEM |
| Classification | Orthosis, Spinal Pedicle 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 | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-26 |
| Decision Date | 1998-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00673978948003 | K982990 | 000 |
| 00721902951855 | K982990 | 000 |
| 00721902951848 | K982990 | 000 |
| 00721902951824 | K982990 | 000 |
| 00721902951800 | K982990 | 000 |
| 00721902951763 | K982990 | 000 |
| 00721902552908 | K982990 | 000 |
| 00721902543432 | K982990 | 000 |
| 00721902543425 | K982990 | 000 |
| 00721902543418 | K982990 | 000 |
| 00721902543371 | K982990 | 000 |
| 00721902543364 | K982990 | 000 |
| 00721902543357 | K982990 | 000 |
| 00721902951886 | K982990 | 000 |
| 00673978036496 | K982990 | 000 |
| 00673978039459 | K982990 | 000 |
| 00673978947990 | K982990 | 000 |
| 00673978049007 | K982990 | 000 |
| 00673978048994 | K982990 | 000 |
| 00673978047348 | K982990 | 000 |
| 00673978042763 | K982990 | 000 |
| 00673978042657 | K982990 | 000 |
| 00673978042640 | K982990 | 000 |
| 00673978039671 | K982990 | 000 |
| 00673978039657 | K982990 | 000 |
| 00673978039640 | K982990 | 000 |
| 00673978039473 | K982990 | 000 |
| 00673978039466 | K982990 | 000 |
| 00721902543340 | K982990 | 000 |