510(k) K173391

OsteoMed QuickFix Hybrid MMF Sterilization Tray by Osteomed, LLC — Product Code KCT

K173391 is an FDA 510(k) premarket notification submitted by Osteomed, LLC for the device "OsteoMed QuickFix Hybrid MMF Sterilization Tray". The FDA issued a decision of Substantially Equivalent on May 10, 2018. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Osteomed, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2018
Date Received
October 30, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type