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 |