The following data is part of a premarket notification filed by Arthrex Inc. with the FDA for Arthrex 3.9mm Corkscrew Suture Anchor.
Device ID | K193157 |
510k Number | K193157 |
Device Name: | Arthrex 3.9mm Corkscrew Suture Anchor |
Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
Applicant | Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
Contact | Jessica L. Singelais |
Correspondent | Jessica L. Singelais Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
Product Code | MAI |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-11-14 |
Decision Date | 2019-12-12 |