FDA 510(k) Application Details - K010545

Device Classification Name	Pin, Fixation, Smooth, Metallic   More FDA Info for this Device
510(K) Number	K010545
Device Name	Pin, Fixation, Smooth, Metallic
Applicant	TRI-MED, INC. 159 KU'UKAMA ST. KAILUA,, HI 96734 US Other 510(k) Applications for this Company
Contact	ROBERT J MEDOFF Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	NDL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/23/2001
Decision Date	06/06/2001
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