FDA.reportPublic FDA data

510(k) K223927

Device
360CAS
Applicant
Kico Knee Innovation Company Pty Limited
510(k) number
K223927
Product code
OLO
Decision
Substantially Equivalent (SESE)
Decision date
2023-01-27
Date received
2022-12-30
Regulation
882.4560
Classification name
Orthopedic Stereotaxic Instrument
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Danyon Munro
Address
Suite 3, Bldg. 1, 20 Bridge St., Pymble Nsw Sydney AU 2073 2073

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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