FDA 510(k) Application Details - K212028

Device Classification Name	Orthopedic Stereotaxic Instrument   More FDA Info for this Device
510(K) Number	K212028
Device Name	Orthopedic Stereotaxic Instrument
Applicant	Republic Spine, LLC 2424 N Federal HW, Suite 257 Boca Raton, FL 33431 US Other 510(k) Applications for this Company
Contact	James Doulgeris 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	06/29/2021
Decision Date	09/27/2021
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