510(k) K153508

Stryker CMF MEDPOR Customized Implant by Stryker — Product Code FWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2016
Date Received
December 7, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Chin, Internal
Device Class
Class II
Regulation Number
878.3550
Review Panel
SU
Submission Type