The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Pushlock Anchors.
Device ID | K101679 |
510k Number | K101679 |
Device Name: | ARTHREX PUSHLOCK ANCHORS |
Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
Applicant | ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
Contact | Courtney Smith |
Correspondent | Courtney Smith ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
Product Code | MAI |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-06-15 |
Decision Date | 2010-10-22 |
Summary: | summary |