The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Univers Revers Ca Heads And Adapters.
Device ID | K151527 |
510k Number | K151527 |
Device Name: | Arthrex Univers Revers CA Heads And Adapters |
Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
Applicant | ARTHREX, INC. 1370 CREEKSIDE BOULEVARD Naples, FL 34108 -1945 |
Contact | Courtney Smith |
Correspondent | Courtney Smith ARTHREX, INC. 1370 CREEKSIDE BOULEVARD Naples, FL 34108 -1945 |
Product Code | HSD |
CFR Regulation Number | 888.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-06-08 |
Decision Date | 2016-04-19 |
Summary: | summary |