510(k) K013781

RIDIDFIX 2.7MM BTB CROSS PIN KIT by Mitek Products — Product Code HTY

K013781 is an FDA 510(k) premarket notification submitted by Mitek Products for the device "RIDIDFIX 2.7MM BTB CROSS PIN KIT". The FDA issued a decision of Substantially Equivalent on February 6, 2002. The device falls under product code HTY (Pin, Fixation, Smooth), a Class II device regulated under 21 CFR 888.3040. Mitek Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2002
Date Received
November 14, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Smooth
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type