The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Swivelock Anchors.
Device ID | K151342 |
510k Number | K151342 |
Device Name: | Arthrex SwiveLock Anchors |
Classification | Fastener, Fixation, Biodegradable, 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 | MAI |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-05-19 |
Decision Date | 2016-03-24 |
Summary: | summary |