The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Encore Reverse Shoulder Prosthesis.
| Device ID | K051075 |
| 510k Number | K051075 |
| Device Name: | ENCORE REVERSE SHOULDER PROSTHESIS |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758 |
| Contact | Christie Shumaker |
| Correspondent | Christie Shumaker 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 | 2005-04-27 |
| Decision Date | 2005-05-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912144674 | K051075 | 000 |
| 00888912024778 | K051075 | 000 |
| 00888912024761 | K051075 | 000 |
| 00888912024754 | K051075 | 000 |
| 00888912024747 | K051075 | 000 |
| 00888912024730 | K051075 | 000 |
| 00888912024723 | K051075 | 000 |
| 00888912024709 | K051075 | 000 |
| 00888912024693 | K051075 | 000 |
| 00888912024655 | K051075 | 000 |
| 00888912024648 | K051075 | 000 |
| 00888912024617 | K051075 | 000 |
| 00888912024402 | K051075 | 000 |
| 00888912144193 | K051075 | 000 |
| 00888912144261 | K051075 | 000 |
| 00888912144667 | K051075 | 000 |
| 00888912144650 | K051075 | 000 |
| 00888912144636 | K051075 | 000 |
| 00888912144629 | K051075 | 000 |
| 00888912144612 | K051075 | 000 |
| 00888912144551 | K051075 | 000 |
| 00888912144544 | K051075 | 000 |
| 00888912144537 | K051075 | 000 |
| 00888912144513 | K051075 | 000 |
| 00888912144490 | K051075 | 000 |
| 00888912144308 | K051075 | 000 |
| 00888912144292 | K051075 | 000 |
| 00888912024396 | K051075 | 000 |