The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Altivate® Anatomic Pegged Glenoid With Markers.
| Device ID | K203026 |
| 510k Number | K203026 |
| Device Name: | AltiVate® Anatomic Pegged Glenoid With Markers |
| 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 | 2020-10-02 |
| Decision Date | 2020-12-23 |
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 |