The following data is part of a premarket notification filed by Koros Usa, Inc. with the FDA for Pectus Strut.
| Device ID | K082399 |
| 510k Number | K082399 |
| Device Name: | PECTUS STRUT |
| Classification | Plate, Fixation, Bone |
| Applicant | KOROS USA, INC. 610 FLINN AVE. Moorpark, CA 93021 |
| Contact | Tibor Koros |
| Correspondent | Tibor Koros KOROS USA, INC. 610 FLINN AVE. Moorpark, CA 93021 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-20 |
| Decision Date | 2009-11-05 |