FDA 510(k) Application Details - K211869

Device Classification Name	Bone Cement   More FDA Info for this Device
510(K) Number	K211869
Device Name	Bone Cement
Applicant	Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi Ve Ticaret Limited S Macun Mahallesi 177 Cadde No:19 H/7 Timko Is Yerleri Ankara 06200 TR Other 510(k) Applications for this Company
Contact	Kenan Kara Other 510(k) Applications for this Contact
Regulation Number	888.3027   More FDA Info for this Regulation Number
Classification Product Code	LOD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/16/2021
Decision Date	05/19/2022
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