FDA 510(k) Application Details - K014189

Device Classification Name	Nail, Fixation, Bone   More FDA Info for this Device
510(K) Number	K014189
Device Name	Nail, Fixation, Bone
Applicant	ORTHOPEDIC DESIGNS, INC. 6965 1ST AVE., NORTH ST. PETERSBURG, FL 33710-8303 US Other 510(k) Applications for this Company
Contact	JOHN SODEIKA Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	JDS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/2001
Decision Date	03/21/2002
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