Device Classification Name |
Fastener, Fixation, Nondegradable, Soft Tissue
More FDA Info for this Device |
510(K) Number |
K231322 |
Device Name |
Fastener, Fixation, Nondegradable, Soft Tissue |
Applicant |
Osteonic Co., Ltd.
1206Ho, 38, Digital-ro, 29-gil, Guro-gu
Seoul 08381 KR
Other 510(k) Applications for this Company
|
Contact |
Da Kyung Ham
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 |
05/08/2023 |
Decision Date |
06/07/2023 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
OR - Orthopedic |
Review Advisory Committee |
OR - Orthopedic |
Statement / Summary / Purged Status |
Summary |
Type |
Special |
Reviewed By Third Party |
N |
Expedited Review |
|