The following data is part of a premarket notification filed by Sofamor Danek Usa,inc. with the FDA for Timesh Titanium Mini-softplate And Micro-soft Plate/screw System.
| Device ID | K973145 |
| 510k Number | K973145 |
| Device Name: | TIMESH TITANIUM MINI-SOFTPLATE AND MICRO-SOFT PLATE/SCREW SYSTEM |
| Classification | Plate, 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 | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-22 |
| Decision Date | 1997-11-19 |
| Summary: | summary |