FDA 510(k) Application Details - K974341

Device Classification Name	Pin, Fixation, Smooth   More FDA Info for this Device
510(K) Number	K974341
Device Name	Pin, Fixation, Smooth
Applicant	MITEK PRODUCTS 60 GLACIER DR. WESTWOOD, MA 02090 US Other 510(k) Applications for this Company
Contact	Robert Zoletti Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	HTY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/18/1997
Decision Date	04/16/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review