Device Classification Name |
Fastener, Fixation, Nondegradable, Soft Tissue
More FDA Info for this Device |
510(K) Number |
K202291 |
Device Name |
Fastener, Fixation, Nondegradable, Soft Tissue |
Applicant |
Yunyi (Beijing) Medical Device Co., Ltd.
Floor 1-4, Building 4, No. 9 Tianfu Street,
Biomedical Base, Daxing District
Beijing 102600 CN
Other 510(k) Applications for this Company
|
Contact |
Xiaowei Liu
Other 510(k) Applications for this Contact |
Regulation Number |
888.3040
More FDA Info for this Regulation Number |
Classification Product Code |
MBI
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
08/12/2020 |
Decision Date |
01/08/2021 |
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 |
|