The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Blunt Tip Screws With Fiber Tape.
Device ID | K143702 |
510k Number | K143702 |
Device Name: | Arthrex Blunt Tip Screws With Fiber Tape |
Classification | Pin, Fixation, Smooth |
Applicant | Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
Contact | David L Roger |
Correspondent | David L Roger Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
Product Code | HTY |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-12-24 |
Decision Date | 2015-04-09 |
Summary: | summary |