The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Corkscrew Ft Iii Suture Anchor With Three #2 Sutures.
Device ID | K062679 |
510k Number | K062679 |
Device Name: | ARTHREX CORKSCREW FT III SUTURE ANCHOR WITH THREE #2 SUTURES |
Classification | Screw, Fixation, Bone |
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 | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-09-08 |
Decision Date | 2006-09-27 |
Summary: | summary |