The following data is part of a premarket notification filed by Depuy Synthes with the FDA for Depuy Synthes 2.7mm Va Lcp Clavicle Plate System, Depuy Synthes 2.7mm Va Lcp Clavicle Hook Plate System.
| Device ID | K203414 |
| 510k Number | K203414 |
| Device Name: | DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System |
| Classification | Plate, Fixation, Bone |
| Applicant | DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Stacey Bonnell |
| Correspondent | Georgina Mueller Synthes GmbH Luzernstrasse 21 Zuchwil, CH 4528 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-19 |
| Decision Date | 2020-12-16 |