FDA 510(k) Application Details - K193580

Device Classification Name	Intraoperative Orthopedic Joint Assessment Aid   More FDA Info for this Device
510(K) Number	K193580
Device Name	Intraoperative Orthopedic Joint Assessment Aid
Applicant	OrthoSensor, Inc. 1855 Griffin Road Suite A-310 Dania Beach, FL 33004 US Other 510(k) Applications for this Company
Contact	Deborah Johnson Other 510(k) Applications for this Contact
Regulation Number	882.4560   More FDA Info for this Regulation Number
Classification Product Code	ONN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2019
Decision Date	04/01/2020
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