The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Tibia-talus-calcaneus Nail.
| Device ID | K950394 |
| 510k Number | K950394 |
| Device Name: | TIBIA-TALUS-CALCANEUS NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Thomas L Craig |
| Correspondent | Thomas L Craig SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-01 |
| Decision Date | 1995-05-19 |