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FDA 510(k) Application Details - K222041
Device Classification Name
More FDA Info for this Device
510(K) Number
K222041
Device Name
CYGNUS-C Standalone ACIF System
Applicant
GS Medical Co. Ltd.
90, Osongsaengmyeong 4-ro Osong-eup, Heungdeok-gu
Cheongju-si 28161 KR
Other 510(k) Applications for this Company
Contact
Sam Camp
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OVE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/11/2022
Decision Date
02/09/2023
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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