The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Trigen Retrograde Femoral, Supracondylar And Tibial Nails.
| Device ID | K051557 |
| 510k Number | K051557 |
| Device Name: | TRIGEN RETROGRADE FEMORAL, SUPRACONDYLAR AND TIBIAL NAILS |
| Classification | Nail, Fixation, Bone |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | David Henley |
| Correspondent | David Henley SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | JDS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-13 |
| Decision Date | 2005-06-30 |
| Summary: | summary |