FDA 510(k) Application Details - K251154

Device Classification Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease   More FDA Info for this Device
510(K) Number	K251154
Device Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant	HT Medical d.b.a. Xenix Medical 111 W Jefferson St., Suite 100 Orlando, FL 32801 US Other 510(k) Applications for this Company
Contact	Tyler Holschlag Other 510(k) Applications for this Contact
Regulation Number	888.3070   More FDA Info for this Regulation Number
Classification Product Code	NKB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/14/2025
Decision Date	06/12/2025
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