The following data is part of a premarket notification filed by Biomet Inc. with the FDA for Juggerstitch Meniscal Repair Device.
| Device ID | K191459 |
| 510k Number | K191459 |
| Device Name: | JuggerStitch Meniscal Repair Device |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Biomet Inc. 56 East Bell Drive Warsaw, IN 46581 |
| Contact | Kyle Ponce |
| Correspondent | Kyle Ponce Biomet Inc. 56 East Bell Drive 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 | 2019-06-03 |
| Decision Date | 2019-09-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868575068 | K191459 | 000 |
| 00887868575051 | K191459 | 000 |