FDA 510(k) Application Details - K020172

Device Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K020172
Device Name	Fastener, Fixation, Nondegradable, Soft Tissue
Applicant	OPUS MEDICAL, INC. 27127 CALLE ARROYO, SUITE 1924 SAN JUAN CAPISTRANO, CA 92675 US Other 510(k) Applications for this Company
Contact	JIM HART Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	MBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/17/2002
Decision Date	07/22/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review