FDA 510(k) Application Details - K243137

Device Classification Name	Orthosis, Spine, Plate, Laminoplasty, Metal   More FDA Info for this Device
510(K) Number	K243137
Device Name	Orthosis, Spine, Plate, Laminoplasty, Metal
Applicant	Curiteva, Inc. 25127 Will McComb Drive Tanner, AL 35671 US Other 510(k) Applications for this Company
Contact	Eric Linder Other 510(k) Applications for this Contact
Regulation Number	888.3050   More FDA Info for this Regulation Number
Classification Product Code	NQW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2024
Decision Date	10/28/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review