The following data is part of a premarket notification filed by Biomet Inc. with the FDA for Allthread Peek Suture Anchor.
| Device ID | K193402 |
| 510k Number | K193402 |
| Device Name: | ALLthread PEEK Suture Anchor |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Biomet Inc. 56 East Bell Drive, PO Box 587 Warsaw, IN 46581 |
| Contact | Haley Pioch |
| Correspondent | Haley Pioch Biomet Inc. 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 | 2019-12-06 |
| Decision Date | 2020-03-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304465589 | K193402 | 000 |
| 00880304464865 | K193402 | 000 |
| 00880304464377 | K193402 | 000 |
| 00887868457456 | K193402 | 000 |
| 00887868457449 | K193402 | 000 |
| 00887868457432 | K193402 | 000 |