The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Fibertape Cerclage.
Device ID | K170206 |
510k Number | K170206 |
Device Name: | Arthrex FiberTape Cerclage |
Classification | Cerclage, Fixation |
Applicant | ARTHREX, INC. 1370 CREEKSIDE BOULEVARD Naples, FL 34108 -1945 |
Contact | Ivette Galmez |
Correspondent | Ivette Galmez ARTHREX, INC. 1370 CREEKSIDE BOULEVARD Naples, FL 34108 -1945 |
Product Code | JDQ |
CFR Regulation Number | 888.3010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-01-24 |
Decision Date | 2017-11-15 |
Summary: | summary |