The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Meniscal Cinch.
Device ID | K073149 |
510k Number | K073149 |
Device Name: | MENISCAL CINCH |
Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
Applicant | ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
Contact | Sally Foust |
Correspondent | Sally Foust ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
Product Code | GAT |
CFR Regulation Number | 878.5000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-11-08 |
Decision Date | 2008-02-11 |
Summary: | summary |