The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Reverse Shoulder Prosthesis Monoblock Stem, Reverse Shoulder Prosthesis Humeral Inserts, Model 510-00-006/012.
| Device ID | K100741 |
| 510k Number | K100741 |
| Device Name: | REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/012 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-16 |
| Decision Date | 2010-08-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912144599 | K100741 | 000 |
| 00888912024846 | K100741 | 000 |
| 00888912024839 | K100741 | 000 |
| 00888912024822 | K100741 | 000 |
| 00888912024815 | K100741 | 000 |
| 00888912024808 | K100741 | 000 |
| 00888912024792 | K100741 | 000 |
| 00888912024785 | K100741 | 000 |
| 00888912024716 | K100741 | 000 |
| 00888912024686 | K100741 | 000 |
| 00888912144223 | K100741 | 000 |
| 00888912144230 | K100741 | 000 |
| 00888912144315 | K100741 | 000 |
| 00888912144582 | K100741 | 000 |
| 00888912144575 | K100741 | 000 |
| 00888912352178 | K100741 | 000 |
| 00888912144766 | K100741 | 000 |
| 00888912144759 | K100741 | 000 |
| 00888912144742 | K100741 | 000 |
| 00888912144735 | K100741 | 000 |
| 00888912144728 | K100741 | 000 |
| 00888912144704 | K100741 | 000 |
| 00888912024679 | K100741 | 000 |