510(k) K180772

Met One Czar Anterior Cervical Plate System by Met One Technologies — Product Code KWQ

K180772 is an FDA 510(k) premarket notification submitted by Met One Technologies for the device "Met One Czar Anterior Cervical Plate System". The FDA issued a decision of Substantially Equivalent on December 17, 2018. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Met One Technologies has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2018
Date Received
March 23, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type