The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Trigen Low Profile Bone Screws.
| Device ID | K161264 |
| 510k Number | K161264 |
| Device Name: | TRIGEN Low Profile Bone Screws |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | SMITH & NEPHEW, INC. 1450 E. BROOKS ROAD Memphis, TN 38116 |
| Contact | Allison Chan |
| Correspondent | Allison Chan SMITH & NEPHEW, INC. 1450 E. BROOKS ROAD Memphis, TN 38116 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-05 |
| Decision Date | 2016-11-23 |
| Summary: | summary |