The following data is part of a premarket notification filed by Biomet Sports Medicine with the FDA for Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors, Juggerknotless Soft Anchors With Needles, Juggerknotless Sof.
| Device ID | K123485 |
| 510k Number | K123485 |
| Device Name: | JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOF |
| 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 | 2012-11-13 |
| Decision Date | 2013-03-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304712577 | K123485 | 000 |
| 00880304672635 | K123485 | 000 |
| 00880304672666 | K123485 | 000 |
| 00880304672673 | K123485 | 000 |
| 00880304672642 | K123485 | 000 |
| 00880304672659 | K123485 | 000 |
| 00880304673649 | K123485 | 000 |
| 00889024583863 | K123485 | 000 |
| 00880304566583 | K123485 | 000 |
| 00880304566613 | K123485 | 000 |
| 00880304566620 | K123485 | 000 |
| 00880304566637 | K123485 | 000 |
| 00880304566644 | K123485 | 000 |
| 00880304567931 | K123485 | 000 |
| 00880304683822 | K123485 | 000 |
| 00880304683839 | K123485 | 000 |
| 00887868462986 | K123485 | 000 |