The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Trigen Low Profile Bone Screw.
| Device ID | K111025 |
| 510k Number | K111025 |
| Device Name: | TRIGEN LOW PROFILE BONE SCREW |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | SMITH & NEPHEW, INC. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Contact | Natalie P Williams |
| Correspondent | Natalie P Williams SMITH & NEPHEW, INC. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-13 |
| Decision Date | 2011-07-01 |
| Summary: | summary |