FDA 510(k) Application Details - K981666

Device Classification Name	Screw, Fixation, Intraosseous   More FDA Info for this Device
510(K) Number	K981666
Device Name	Screw, Fixation, Intraosseous
Applicant	BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 WARSAW, IN 46581-0587 US Other 510(k) Applications for this Company
Contact	MARY VERSTYNEN Other 510(k) Applications for this Contact
Regulation Number	872.4880   More FDA Info for this Regulation Number
Classification Product Code	DZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/11/1998
Decision Date	11/03/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review