The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Turon Rsp Socket Shell-neutral Model 508-02-000, Turon Rsp Socket Shell-offset Model 508-02-001.
| Device ID | K111629 |
| 510k Number | K111629 |
| Device Name: | TURON RSP SOCKET SHELL-NEUTRAL MODEL 508-02-000, TURON RSP SOCKET SHELL-OFFSET MODEL 508-02-001 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-13 |
| Decision Date | 2011-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912144346 | K111629 | 000 |
| 00888912144322 | K111629 | 000 |