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 | K041066 |
| 510k Number | K041066 |
| Device Name: | ENCORE REVERSE SHOULDER PROSTHESIS |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758 |
| Contact | Debbie De Los Santos |
| Correspondent | Debbie De Los Santos 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 | 2004-04-23 |
| Decision Date | 2005-03-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912144117 | K041066 | 000 |
| 00888912024525 | K041066 | 000 |
| 00888912024518 | K041066 | 000 |
| 00888912024501 | K041066 | 000 |
| 00888912024495 | K041066 | 000 |
| 00888912024488 | K041066 | 000 |
| 00888912024471 | K041066 | 000 |
| 00888912024464 | K041066 | 000 |
| 00888912024457 | K041066 | 000 |
| 00888912024440 | K041066 | 000 |
| 00888912024433 | K041066 | 000 |
| 00888912024426 | K041066 | 000 |
| 00888912024419 | K041066 | 000 |
| 00888912024389 | K041066 | 000 |
| 00888912024532 | K041066 | 000 |
| 00888912024549 | K041066 | 000 |
| 00888912144100 | K041066 | 000 |
| 00888912144087 | K041066 | 000 |
| 00888912144070 | K041066 | 000 |
| 00888912143905 | K041066 | 000 |
| 00888912143844 | K041066 | 000 |
| 00888912024631 | K041066 | 000 |
| 00888912024624 | K041066 | 000 |
| 00888912024600 | K041066 | 000 |
| 00888912024594 | K041066 | 000 |
| 00888912024587 | K041066 | 000 |
| 00888912024570 | K041066 | 000 |
| 00888912024563 | K041066 | 000 |
| 00888912024556 | K041066 | 000 |
| 00888912024372 | K041066 | 000 |