The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Locking Bone Plate System (locking Bone Plates And Screws).
| Device ID | K033669 |
| 510k Number | K033669 |
| Device Name: | SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS) |
| Classification | Plate, Fixation, Bone |
| Applicant | SMITH & NEPHEW, INC. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Contact | David Henley |
| Correspondent | David Henley SMITH & NEPHEW, INC. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-21 |
| Decision Date | 2003-12-10 |
| Summary: | summary |