FDA 510(k) Application Details - K171831

Device Classification Name	Screw, Fixation, Intraosseous   More FDA Info for this Device
510(K) Number	K171831
Device Name	Screw, Fixation, Intraosseous
Applicant	Intra-Lock International, Inc. 6560 West Rogers Circle Bldg 24 Boca Raton, FL 33487 US Other 510(k) Applications for this Company
Contact	Mary L. Jean 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	06/20/2017
Decision Date	10/26/2017
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