The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Juggerstitch Meniscal Repair Device.
| Device ID | K150424 |
| 510k Number | K150424 |
| Device Name: | JuggerStitch Meniscal Repair Device |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE PO BOX 587 Warsaw, IN 46581 |
| Contact | Patricia S. Beres |
| Correspondent | Patricia S. Beres BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE PO BOX 587 Warsaw, IN 46581 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-19 |
| Decision Date | 2015-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304806832 | K150424 | 000 |
| 00880304806825 | K150424 | 000 |
| 00880304806818 | K150424 | 000 |
| 00880304690073 | K150424 | 000 |
| 00880304690066 | K150424 | 000 |