The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Reverse Shoulder Prosthesis Monoblock Hemi Adapter.
| Device ID | K111735 |
| 510k Number | K111735 |
| Device Name: | REVERSE SHOULDER PROSTHESIS MONOBLOCK HEMI ADAPTER |
| 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 | 2011-06-21 |
| Decision Date | 2011-10-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912144797 | K111735 | 000 |
| 00888912144773 | K111735 | 000 |