FDA 510(k) Application Details - K243537

Device Classification Name	Cement, Bone, Vertebroplasty   More FDA Info for this Device
510(K) Number	K243537
Device Name	Cement, Bone, Vertebroplasty
Applicant	XELITE BIOMED LTD. 2F., No. 9, Aly. 2, Siwei Ln., Zhongzheng Rd., Xindian Dist. Taiwan (R.O.C.) New Taipei City 231022 TW Other 510(k) Applications for this Company
Contact	Wei Chun Chang 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	11/15/2024
Decision Date	04/11/2025
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