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FDA 510(k) Application Details - K202663
Device Classification Name
Fastener, Fixation, Nondegradable, Soft Tissue
More FDA Info for this Device
510(K) Number
K202663
Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Applicant
Osteonic Co., Ltd.
38 Digital-ro 29-gil
Guro-gu 08381 KR
Other 510(k) Applications for this Company
Contact
Dakyung 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
09/14/2020
Decision Date
06/07/2021
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
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