The following data is part of a premarket notification filed by Sofamor Danek Usa,inc. with the FDA for Titanium Gdlh Posterior Spinal System.
| Device ID | K954645 |
| 510k Number | K954645 |
| Device Name: | TITANIUM GDLH POSTERIOR SPINAL SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| 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 | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-10 |
| Decision Date | 1996-01-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00673978995168 | K954645 | 000 |
| 00721902975189 | K954645 | 000 |
| 00721902975219 | K954645 | 000 |
| 00721902975226 | K954645 | 000 |
| 00721902975233 | K954645 | 000 |
| 00673978061825 | K954645 | 000 |
| 00673978130316 | K954645 | 000 |
| 00673978130347 | K954645 | 000 |
| 00673978130361 | K954645 | 000 |
| 00673978130392 | K954645 | 000 |
| 00673978130408 | K954645 | 000 |
| 00673978130415 | K954645 | 000 |
| 00673978130422 | K954645 | 000 |
| 00721902975158 | K954645 | 000 |