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FDA 510(k) Application Details - K223927
Device Classification Name
Orthopedic Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K223927
Device Name
Orthopedic Stereotaxic Instrument
Applicant
Kico Knee Innovation Company Pty Limited
Suite 3, Building 1, 20 Bridge Street, Pymble NSW
Sydney 2073 AU
Other 510(k) Applications for this Company
Contact
Danyon Munro
Other 510(k) Applications for this Contact
Regulation Number
882.4560
More FDA Info for this Regulation Number
Classification Product Code
OLO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/30/2022
Decision Date
01/27/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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