The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Biomet Sports Medicine Juggerknot Soft Anchor.
Device ID | K110145 |
510k Number | K110145 |
Device Name: | BIOMET SPORTS MEDICINE JUGGERKNOT SOFT ANCHOR |
Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
Applicant | BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
Contact | Elizabeth Wray |
Correspondent | Elizabeth Wray BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
Product Code | MBI |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-01-18 |
Decision Date | 2011-03-04 |
Summary: | summary |