FDA 510(k) Application Details - K040363

Device Classification Name	Fixation Accessory   More FDA Info for this Device
510(K) Number	K040363
Device Name	Fixation Accessory
Applicant	THE JEROME GROUP, INC. 305 HARPER DR. MOORESTOWN, NJ 08057 US Other 510(k) Applications for this Company
Contact	RONALD KOWALSKI Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	LYT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/13/2004
Decision Date	04/12/2004
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