The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Rsp Monoblock Stem With P2 Coating, Size 6.
| Device ID | K140904 |
| 510k Number | K140904 |
| Device Name: | RSP MONOBLOCK STEM WITH P2 COATING, SIZE 6 |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| 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 | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-09 |
| Decision Date | 2014-05-06 |
| Summary: | summary |