The following data is part of a premarket notification filed by Arthrex Inc. with the FDA for Arthrex Univers Ii Shoulder Prosthesis System: Titanium Humeral Heads.
Device ID | K182799 |
510k Number | K182799 |
Device Name: | Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads |
Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
Applicant | Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
Contact | David L Rogers |
Correspondent | David L Rogers Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
Product Code | KWS |
CFR Regulation Number | 888.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-10-02 |
Decision Date | 2019-03-08 |