The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 3.5mm Lcp Clavicle Plate System.
| Device ID | K111540 |
| 510k Number | K111540 |
| Device Name: | SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Thomas N Shea |
| Correspondent | Thomas N Shea SYNTHES (USA) 1301 Goshen Parkway West Chester, PA 19380 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-02 |
| Decision Date | 2011-08-08 |
| Summary: | summary |