The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Distal Radius System.
Device ID | K143749 |
510k Number | K143749 |
Device Name: | Arthrex Distal Radius System |
Classification | Plate, Fixation, Bone |
Applicant | Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
Contact | Laura Medlin |
Correspondent | Laura Medlin Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-12-31 |
Decision Date | 2015-04-03 |
Summary: | summary |