FDA 510(k) Application Details - K242616

Device Classification Name	Intraoperative Orthopedic Joint Assessment Aid   More FDA Info for this Device
510(K) Number	K242616
Device Name	Intraoperative Orthopedic Joint Assessment Aid
Applicant	OrthAlign, Inc 153 Technology Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Karyl Haskell 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	09/03/2024
Decision Date	10/03/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review