FDA 510(k) Application Details - K192495

Device Classification Name	Orthopedic Stereotaxic Instrument   More FDA Info for this Device
510(K) Number	K192495
Device Name	Orthopedic Stereotaxic Instrument
Applicant	Osseus Fusion Systems 2703 Mockingbird Lane, Suite 102 Dallas, TX 75235 US Other 510(k) Applications for this Company
Contact	Robert Pace Other 510(k) Applications for this Contact
Regulation Number	882.4560   More FDA Info for this Regulation Number
Classification Product Code	OLO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/11/2019
Decision Date	01/17/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review