The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Short Suture Anchors.
Device ID | K151092 |
510k Number | K151092 |
Device Name: | Arthrex Short Suture Anchors |
Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
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 | MBI |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-04-23 |
Decision Date | 2016-02-23 |
Summary: | summary |