The following data is part of a premarket notification filed by Arthrex Inc. with the FDA for Arthrex Low Profile Screws.
Device ID | K203239 |
510k Number | K203239 |
Device Name: | Arthrex Low Profile Screws |
Classification | Screw, Fixation, Bone |
Applicant | Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
Contact | Samantha Passman |
Correspondent | Samantha Passman 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 | 2020-11-03 |
Decision Date | 2020-12-30 |