The following data is part of a premarket notification filed by Depuy Synthes with the FDA for Depuy Synthes 2.7mm Straight And 2.7mm Adaption Plates (modular Mini Fragment Lcp System).
| Device ID | K211051 |
| 510k Number | K211051 |
| Device Name: | DePuy Synthes 2.7mm Straight And 2.7mm Adaption Plates (Modular Mini Fragment LCP System) |
| Classification | Plate, Fixation, Bone |
| Applicant | DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Stacey Bonnell |
| Correspondent | Ann-christin Ponick DePuy Synthes Luzernstrasse 21 Zuchwil, CH 4528 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-08 |
| Decision Date | 2021-06-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886982307538 | K211051 | 000 |
| 10886982307491 | K211051 | 000 |
| 10886982307484 | K211051 | 000 |
| 10886982307477 | K211051 | 000 |
| 10886982307460 | K211051 | 000 |
| 10886982307453 | K211051 | 000 |