The following data is part of a premarket notification filed by Biomet Sports Medicine with the FDA for Juggerknot Mini Soft Anchor.
Device ID | K140908 |
510k Number | K140908 |
Device Name: | JUGGERKNOT MINI SOFT ANCHOR |
Classification | Screw, Fixation, Intraosseous |
Applicant | BIOMET SPORTS MEDICINE 56 EAST BELL DRIVE Warsaw, IN 46582 |
Contact | Jared Cooper |
Correspondent | Jared Cooper BIOMET SPORTS MEDICINE 56 EAST BELL DRIVE Warsaw, IN 46582 |
Product Code | DZL |
CFR Regulation Number | 872.4880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-04-09 |
Decision Date | 2014-10-02 |
Summary: | summary |