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360cas

FDA UDI

Class II (US FDA UDI)

by Kico Knee Innovation Company Pty Limited

Identity

Trade Name
360CAS FDA UDI
Generic Name
Robotic surgical navigation system application software FDA UDI
Device Name
Male Bone Fixator FDA UDI
Model / Reference
KIC-DND-0004 FDA UDI
Description
Male Bone Fixator FDA UDI

Identifiers

Primary DI / UDI-DI
B432360CAS00040 FDA UDI
510(k) Number
K223927 FDA UDI
FDA Product Code
OLO FDA UDI
GMDN Term
Robotic surgical navigation system application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4560 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Robotic surgical navigation system application software

360cas by Kico Knee Innovation Company Pty Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Robotic surgical navigation system application software.

Cleared under the same submission

K223927 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kico Knee Innovation Company Pty Limited

Sources (1)

  • FDA UDI 1eb30b8e-778d-46c0-801a-7cd147c37adb 34 fields · synced Jun 6, 2026