The following data is part of a premarket notification filed by Sofamor Danek Usa,inc. with the FDA for Timesh System.
| Device ID | K974017 |
| 510k Number | K974017 |
| Device Name: | TIMESH SYSTEM |
| Classification | Plate, Fixation, Bone |
| 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 | HRS |
| Subsequent Product Code | EZX |
| Subsequent Product Code | GXR |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-22 |
| Decision Date | 1998-01-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994284600 | K974017 | 000 |
| 00721902742750 | K974017 | 000 |
| 00721902742774 | K974017 | 000 |
| 00721902742781 | K974017 | 000 |
| 00721902742804 | K974017 | 000 |
| 00721902742811 | K974017 | 000 |
| 00721902742828 | K974017 | 000 |
| 00721902742835 | K974017 | 000 |
| 00613994284587 | K974017 | 000 |
| 00613994284594 | K974017 | 000 |
| 00721902742743 | K974017 | 000 |