The following data is part of a premarket notification filed by Sofamor Danek Usa,inc. with the FDA for Titanium Dyna-lok Spinal System.
| Device ID | K953635 |
| 510k Number | K953635 |
| Device Name: | TITANIUM DYNA-LOK SPINAL SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | SOFAMOR DANEK USA,INC. 100 PUBLISHERS DR. Winona Lake, IN 46590 |
| Contact | Richard W Treharne |
| Correspondent | Richard W Treharne SOFAMOR DANEK USA,INC. 100 PUBLISHERS DR. Winona Lake, IN 46590 |
| 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 | 1995-08-02 |
| Decision Date | 1995-10-30 |