The following data is part of a premarket notification filed by Encore Medical, Inc. with the FDA for Encore Reverse Shoulder Prosthesis Humeral Stem Adapter.
| Device ID | K052086 |
| 510k Number | K052086 |
| Device Name: | ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | ENCORE MEDICAL, INC. 9800 METRIC BLVD. Austin, TX 78758 |
| Contact | Christie Shumaker |
| Correspondent | Christie Shumaker ENCORE MEDICAL, INC. 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 | 2005-08-02 |
| Decision Date | 2005-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912144032 | K052086 | 000 |
| 00888912144001 | K052086 | 000 |