The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Altivate® Anatomic Shoulder Ag E+™ With Markers.
| Device ID | K213387 |
| 510k Number | K213387 |
| Device Name: | AltiVate® Anatomic Shoulder AG E+™ With Markers |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | Encore Medical, L.P. 9800 Metric Boulevard Austin, TX 78758 |
| Contact | Michael Siano |
| Correspondent | Michael A Siano Encore Medical, L.P. 9800 Metric Boulevard 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 | 2021-10-14 |
| Decision Date | 2022-07-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190446728993 | K213387 | 000 |
| 00190446698395 | K213387 | 000 |
| 00190446698388 | K213387 | 000 |
| 00190446698371 | K213387 | 000 |
| 00190446698364 | K213387 | 000 |
| 00190446698357 | K213387 | 000 |
| 00190446698340 | K213387 | 000 |
| 00190446698333 | K213387 | 000 |
| 00190446698326 | K213387 | 000 |
| 00190446698319 | K213387 | 000 |
| 00190446698302 | K213387 | 000 |
| 00190446698296 | K213387 | 000 |
| 00190446698289 | K213387 | 000 |
| 00190446698272 | K213387 | 000 |
| 00190446698401 | K213387 | 000 |
| 00190446698418 | K213387 | 000 |
| 00190446698425 | K213387 | 000 |
| 00190446729280 | K213387 | 000 |
| 00190446729273 | K213387 | 000 |
| 00190446729266 | K213387 | 000 |
| 00190446729259 | K213387 | 000 |
| 00190446729068 | K213387 | 000 |
| 00190446729129 | K213387 | 000 |
| 00190446729112 | K213387 | 000 |
| 00190446729105 | K213387 | 000 |
| 00190446729099 | K213387 | 000 |
| 00190446698463 | K213387 | 000 |
| 00190446698456 | K213387 | 000 |
| 00190446698449 | K213387 | 000 |
| 00190446698432 | K213387 | 000 |
| 00190446698265 | K213387 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ALTIVATE 87175598 5487307 Live/Registered |
Encore Medical, L.P. 2016-09-19 |
![]() ALTIVATE 87052765 5283648 Live/Registered |
ALTIVATE CONSULTING DMCC 2016-05-27 |
![]() ALTIVATE 86605047 not registered Dead/Abandoned |
Encore Medical, L.P. 2015-04-21 |