510(k) K142655

CB PROT II Posterior Spinal System by Chin Bone Technique Corp — Product Code MNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2015
Date Received
September 18, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spondylolisthesis Spinal Fixation
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type