The following data is part of a premarket notification filed by Osteomed Llc with the FDA for Osteomed Quickfix Hybrid Mmf Sterilization Tray.
| Device ID | K173391 |
| 510k Number | K173391 |
| Device Name: | OsteoMed QuickFix Hybrid MMF Sterilization Tray |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | OsteoMed LLC 3885 Arapaho Rd Addison, TX 75001 |
| Contact | Jessica M. Ruperto |
| Correspondent | Kathryn A. Jayne OsteoMed LLC 3885 Arapaho Rd Addison, TX 75001 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-30 |
| Decision Date | 2018-05-10 |
| Summary: | summary |