FDA 510(k) Application Details - K983757

Device Classification Name	Pin, Fixation, Threaded   More FDA Info for this Device
510(K) Number	K983757
Device Name	Pin, Fixation, Threaded
Applicant	SYNTEC SCIENTIFIC CORP. 2, KUNG SAN ROAD, CHAUN SHING INDUSTRIAL ZONE, SHEN KANG CHANG HUA 509 TW Other 510(k) Applications for this Company
Contact	TED Y SHI Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	JDW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/23/1998
Decision Date	12/04/1998
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