The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Reverse Shoulder Prosthesis Monoblock.
| Device ID | K130048 |
| 510k Number | K130048 |
| Device Name: | REVERSE SHOULDER PROSTHESIS MONOBLOCK |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758 |
| Contact | Teffany Hutto |
| Correspondent | Teffany Hutto ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758 |
| 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 | 2013-01-08 |
| Decision Date | 2013-10-29 |
| Summary: | summary |