The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Mectascrew Peek Interference Screw.
| Device ID | K190892 |
| 510k Number | K190892 |
| Device Name: | MectaScrew PEEK Interference Screw |
| 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 | 2019-04-05 |
| Decision Date | 2019-06-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630040723558 | K190892 | 000 |
| 07630040723381 | K190892 | 000 |
| 07630040723398 | K190892 | 000 |
| 07630040723404 | K190892 | 000 |
| 07630040723411 | K190892 | 000 |
| 07630040723428 | K190892 | 000 |
| 07630040723435 | K190892 | 000 |
| 07630040723442 | K190892 | 000 |
| 07630040723459 | K190892 | 000 |
| 07630040723466 | K190892 | 000 |
| 07630040723473 | K190892 | 000 |
| 07630040723480 | K190892 | 000 |
| 07630040723497 | K190892 | 000 |
| 07630040723503 | K190892 | 000 |
| 07630040723510 | K190892 | 000 |
| 07630040723527 | K190892 | 000 |
| 07630040723534 | K190892 | 000 |
| 07630040723541 | K190892 | 000 |
| 07630040723374 | K190892 | 000 |