510(k) K170877

Parcus SLiK Fix Screw by Parcus Medical — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2017
Date Received
March 24, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type