The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Mectalock Peek Suture Anchor.
| Device ID | K190474 |
| 510k Number | K190474 |
| Device Name: | MectaLock PEEK Suture Anchor |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Medacta International SA Strada Regina Castel San Pietro, CH Ch-6874 |
| Contact | Stefano Baj |
| Correspondent | Chris Lussier Medacta USA 3973 Delp Street Memphis, TN 38118 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-27 |
| Decision Date | 2019-05-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630040727822 | K190474 | 000 |
| 07630040727815 | K190474 | 000 |
| 07630040727808 | K190474 | 000 |
| 07630040727778 | K190474 | 000 |
| 07630040727761 | K190474 | 000 |
| 07630040727754 | K190474 | 000 |