The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Epoca Shoulder Prosthesis System.
| Device ID | K083439 |
| 510k Number | K083439 |
| Device Name: | SYNTHES EPOCA SHOULDER PROSTHESIS SYSTEM |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Contact | Amnon Talmor |
| Correspondent | Amnon Talmor SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Product Code | MBF |
| Subsequent Product Code | HSD |
| Subsequent Product Code | KWT |
| CFR Regulation Number | 888.3670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-20 |
| Decision Date | 2009-02-05 |
| Summary: | summary |