510(k) K163279

Medtronic Transportation/Sterilization Cassettes by Medtronic Sofamor Danek USA, Inc. — Product Code KCT

K163279 is an FDA 510(k) premarket notification submitted by Medtronic Sofamor Danek USA, Inc. for the device "Medtronic Transportation/Sterilization Cassettes". The FDA issued a decision of Substantially Equivalent on Feb 23, 2017. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Medtronic Sofamor Danek USA, Inc. has 181 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 23, 2017
Date Received
Nov 21, 2016
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
510(k)