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 |