FDA 510(k) Application Details - K221307

Device Classification Name	Orthosis, Cervical Pedicle Screw Spinal Fixation   More FDA Info for this Device
510(K) Number	K221307
Device Name	Orthosis, Cervical Pedicle Screw Spinal Fixation
Applicant	Spinal Simplicity LLC 6363 College Boulevard Suite 320 Overland Park, KS 66211 US Other 510(k) Applications for this Company
Contact	Adam Rogers Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	NKG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/05/2022
Decision Date	07/10/2023
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