The following data is part of a premarket notification filed by Avinent Implant System, S.l.u. with the FDA for Avinent Surgical Tray.
| Device ID | K191566 |
| 510k Number | K191566 |
| Device Name: | Avinent Surgical Tray |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | AVINENT Implant System, S.L.U. Pol. Ind. Santa Anna Santpedor, ES 08251 |
| Contact | Anna Cortina |
| Correspondent | Angela Blackwell Blackwell Device Consulting P.O. Box 718 Gresham, OR 97030 -0172 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-13 |
| Decision Date | 2020-03-06 |