FDA 510(k) Application Details - K240233

Device Classification Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease   More FDA Info for this Device
510(K) Number	K240233
Device Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant	S H Pitkar Orthotools Pvt Ltd. Plot No. EL 32, J Block, MIDC Bhosari Pune 411026 IN Other 510(k) Applications for this Company
Contact	Vivek Mangalwedhekar 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	01/29/2024
Decision Date	09/09/2024
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