FDA 510(k) Application Details - K213454

Device Classification Name	Drills, Burrs, Trephines & Accessories (Simple, Powered)   More FDA Info for this Device
510(K) Number	K213454
Device Name	Drills, Burrs, Trephines & Accessories (Simple, Powered)
Applicant	Medtronic Powered Surgical Solutions 4620 North Beach Street Fort Worth, TX 76137 US Other 510(k) Applications for this Company
Contact	Carrie Eddings Other 510(k) Applications for this Contact
Regulation Number	882.4310   More FDA Info for this Regulation Number
Classification Product Code	HBE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/26/2021
Decision Date	11/23/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review