FDA 510(k) Application Details - K211797

Device Classification Name	Cement, Bone, Vertebroplasty   More FDA Info for this Device
510(K) Number	K211797
Device Name	Cement, Bone, Vertebroplasty
Applicant	GS Medical Co. Ltd. 90, Osongsaengmyeong 4-ro Osong-eup, Heungdeok-gu Cheongju-si 28161 KR Other 510(k) Applications for this Company
Contact	Sam Camp Other 510(k) Applications for this Contact
Regulation Number	888.3027   More FDA Info for this Regulation Number
Classification Product Code	NDN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/10/2021
Decision Date	10/28/2021
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