The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Encore Shoulder Primary Humeral Stem, Model 500-00, Encore Shoulder Humeral Head, Model 520-38.
| Device ID | K080402 |
| 510k Number | K080402 |
| Device Name: | ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL HEAD, MODEL 520-38 |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| 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 | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-14 |
| Decision Date | 2008-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912145275 | K080402 | 000 |
| 00888912025041 | K080402 | 000 |
| 00888912025058 | K080402 | 000 |
| 00888912025065 | K080402 | 000 |
| 00888912025072 | K080402 | 000 |
| 00888912025089 | K080402 | 000 |
| 00888912114394 | K080402 | 000 |
| 00888912144827 | K080402 | 000 |
| 00888912144896 | K080402 | 000 |
| 00888912025034 | K080402 | 000 |
| 00888912025027 | K080402 | 000 |
| 00888912024891 | K080402 | 000 |
| 00888912024907 | K080402 | 000 |
| 00888912024914 | K080402 | 000 |
| 00888912024921 | K080402 | 000 |
| 00888912024983 | K080402 | 000 |
| 00888912024990 | K080402 | 000 |
| 00888912025003 | K080402 | 000 |
| 00888912025010 | K080402 | 000 |
| 00888912144902 | K080402 | 000 |
| 00888912144971 | K080402 | 000 |
| 00888912145190 | K080402 | 000 |
| 00888912145206 | K080402 | 000 |
| 00888912145213 | K080402 | 000 |
| 00888912145220 | K080402 | 000 |
| 00888912145237 | K080402 | 000 |
| 00888912145244 | K080402 | 000 |
| 00888912145251 | K080402 | 000 |
| 00888912145268 | K080402 | 000 |
| 00888912145169 | K080402 | 000 |
| 00888912145152 | K080402 | 000 |
| 00888912144988 | K080402 | 000 |
| 00888912144995 | K080402 | 000 |
| 00888912145008 | K080402 | 000 |
| 00888912145015 | K080402 | 000 |
| 00888912145022 | K080402 | 000 |
| 00888912145114 | K080402 | 000 |
| 00888912145138 | K080402 | 000 |
| 00888912145145 | K080402 | 000 |
| 00888912024884 | K080402 | 000 |