The following data is part of a premarket notification filed by Aston Medical with the FDA for Duocentric Reversed Shoulder Prosthesis.
| Device ID | K133462 |
| 510k Number | K133462 |
| Device Name: | DUOCENTRIC REVERSED SHOULDER PROSTHESIS |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| 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 | KWS |
| Subsequent Product Code | HSD |
| Subsequent Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-12 |
| Decision Date | 2014-02-07 |
| Summary: | summary |