FDA 510(k) Application Details - K251725

Device Classification Name	Orthosis, Cervical Pedicle Screw Spinal Fixation   More FDA Info for this Device
510(K) Number	K251725
Device Name	Orthosis, Cervical Pedicle Screw Spinal Fixation
Applicant	CG MedTech Co., Ltd. 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si 11781 KR Other 510(k) Applications for this Company
Contact	Jeongah Kim 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	06/05/2025
Decision Date	06/25/2025
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