FDA 510(k) Application Details - K231213

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K231213
Device Name	Plate, Fixation, Bone
Applicant	Hankil Tech Medical Co., Ltd 452-29, Pureundeulpan-ro, Paltan-myeon Hwaseong-si 18532 KR Other 510(k) Applications for this Company
Contact	Kim Jeong-Yup 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	04/28/2023
Decision Date	01/19/2024
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