510(k) K170939

Supplemental Instrument Trays by Nuvasive Specialized Orthopedics, Incorporated — Product Code KCT

K170939 is an FDA 510(k) premarket notification submitted by Nuvasive Specialized Orthopedics, Incorporated for the device "Supplemental Instrument Trays". The FDA issued a decision of Substantially Equivalent on August 8, 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. Nuvasive Specialized Orthopedics, Incorporated has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2017
Date Received
March 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