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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
Large CAS Tracker FDA UDI
Model / Reference
KIC-DND-0003 FDA UDI
Description
Large CAS Tracker FDA UDI

Identifiers

Primary DI / UDI-DI
B432360CAS00030 FDA UDI
510(k) Number
K213380 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
Hydrogen Peroxide 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

K213380 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 0a5be178-c4a5-48fd-b5d4-4d38766f54d6 34 fields · synced Jun 8, 2026