The following data is part of a premarket notification filed by Arthrex Inc. with the FDA for Arthrex Pushlock Tenodesis Anchor.
Device ID | K181513 |
510k Number | K181513 |
Device Name: | Arthrex PushLock Tenodesis Anchor |
Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
Applicant | Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
Contact | Ivette Galmez |
Correspondent | Ivette Galmez Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
Product Code | MBI |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-06-08 |
Decision Date | 2018-08-30 |
Summary: | summary |