The following data is part of a premarket notification filed by Biomet Sports Medicine with the FDA for Biomet Sports Medicine Juggerknot (tm) Mini Soft Anchor.
| Device ID | K110879 |
| 510k Number | K110879 |
| Device Name: | BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | BIOMET SPORTS MEDICINE 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Elizabeth Wray |
| Correspondent | Elizabeth Wray BIOMET SPORTS MEDICINE 56 EAST BELL DRIVE P.O. 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 | 2011-03-30 |
| Decision Date | 2011-08-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304528499 | K110879 | 000 |
| 00880304523418 | K110879 | 000 |
| 00880304523401 | K110879 | 000 |
| 00880304520950 | K110879 | 000 |
| 00880304520820 | K110879 | 000 |
| 00887868511912 | K110879 | 000 |