The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Cmc Mini Tightrope.
Device ID | K140328 |
510k Number | K140328 |
Device Name: | CMC MINI TIGHTROPE |
Classification | Washer, Bolt Nut |
Applicant | ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
Contact | Nancy Hoft |
Correspondent | Nancy Hoft ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
Product Code | HTN |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-02-10 |
Decision Date | 2014-03-10 |
Summary: | summary |