510(k) K150759

Hyper-C Anterior Cervical Plate System by Degen Medical — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2015
Date Received
March 23, 2015
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