The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Encore Humeral Shoulder Stem.
| Device ID | K141990 |
| 510k Number | K141990 |
| Device Name: | ENCORE HUMERAL SHOULDER STEM |
| 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 |
| Subsequent Product Code | HSD |
| Subsequent Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-22 |
| Decision Date | 2014-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190446323006 | K141990 | 000 |
| 00888912168410 | K141990 | 000 |
| 00888912168403 | K141990 | 000 |
| 00888912168397 | K141990 | 000 |
| 00888912168380 | K141990 | 000 |
| 00888912168373 | K141990 | 000 |
| 00888912168366 | K141990 | 000 |
| 00888912168359 | K141990 | 000 |
| 00888912168342 | K141990 | 000 |
| 00888912168335 | K141990 | 000 |
| 00888912168328 | K141990 | 000 |
| 00888912168311 | K141990 | 000 |
| 00888912168304 | K141990 | 000 |
| 00888912168298 | K141990 | 000 |
| 00888912168281 | K141990 | 000 |
| 00888912168274 | K141990 | 000 |
| 00888912168267 | K141990 | 000 |
| 00888912168250 | K141990 | 000 |
| 00888912168427 | K141990 | 000 |
| 00888912168434 | K141990 | 000 |
| 00190446322993 | K141990 | 000 |
| 00190446322986 | K141990 | 000 |
| 00190446322979 | K141990 | 000 |
| 00190446322955 | K141990 | 000 |
| 00888912168564 | K141990 | 000 |
| 00888912168557 | K141990 | 000 |
| 00888912168540 | K141990 | 000 |
| 00888912168533 | K141990 | 000 |
| 00888912168526 | K141990 | 000 |
| 00888912168519 | K141990 | 000 |
| 00888912168502 | K141990 | 000 |
| 00888912168496 | K141990 | 000 |
| 00888912168489 | K141990 | 000 |
| 00888912168472 | K141990 | 000 |
| 00888912168465 | K141990 | 000 |
| 00888912168458 | K141990 | 000 |
| 00888912168441 | K141990 | 000 |
| 00888912168243 | K141990 | 000 |