The following data is part of a premarket notification filed by Arthrex Inc. with the FDA for Arthrex 2.5 Mm Tenodesis Screw.
Device ID | K183395 |
510k Number | K183395 |
Device Name: | Arthrex 2.5 Mm Tenodesis Screw |
Classification | Screw, Fixation, Bone |
Applicant | Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
Contact | Rebecca R. Homan |
Correspondent | Rebecca R. Homan Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-12-07 |
Decision Date | 2019-04-17 |