The following data is part of a premarket notification filed by Aston Medical with the FDA for Duocentric Reversed.
| Device ID | K103251 |
| 510k Number | K103251 |
| Device Name: | DUOCENTRIC REVERSED |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | ASTON MEDICAL 577 North Hope Ave Santa Barbara, CA 93110 |
| Contact | Catherine Gloster |
| Correspondent | Catherine Gloster ASTON MEDICAL 577 North Hope Ave Santa Barbara, CA 93110 |
| Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-03 |
| Decision Date | 2011-10-28 |
| Summary: | summary |