FDA 510(k) Application Details - K233873

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K233873
Device Name	Plate, Fixation, Bone
Applicant	Ortho Life Systems Private Limited D-111, Okhla Industrial Area, Phase 1, New Delhi Okhla 110020 IN Other 510(k) Applications for this Company
Contact	Tamandeep Kochhar Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	HRS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/07/2023
Decision Date	04/26/2024
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