The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Thackray Titanium Mini-plating System.
| Device ID | K905774 |
| 510k Number | K905774 |
| Device Name: | THACKRAY TITANIUM MINI-PLATING SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | David Kotkovetz |
| Correspondent | David Kotkovetz DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-27 |
| Decision Date | 1991-06-13 |