The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 2.7 Mm/3.5 Mm Lcp Distal Fibula Plates.
| Device ID | K083213 |
| 510k Number | K083213 |
| Device Name: | SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung SYNTHES (USA) 1301 GOSHEN PKWY. 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 | 2008-10-31 |
| Decision Date | 2008-12-30 |
| Summary: | summary |