FDA 510(k) Application Details - K231807

Device Classification Name	More FDA Info for this Device
510(K) Number	K231807
Device Name	primaLOKÖ SP Interspinous Fusion System
Applicant	Wenzel Spine, Inc. 1130 Rutherford Lane, Suite 200 Austin, TX 78753 US Other 510(k) Applications for this Company
Contact	William Wilson Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PEK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/20/2023
Decision Date	08/15/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review