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FDA 510(k)

360KS Implant Positioning System

K-Number: K163405 · 2017-03-21

ApplicantKico Knee Innovation Company Pty Limited
Decision Date2017-03-21
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

360KS Implant Positioning System is a medical device manufactured by Kico Knee Innovation Company Pty Limited. It received FDA 510(k) clearance on 2017-03-21 under approval number K163405. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 360KS Implant Positioning System?

360KS Implant Positioning System is a medical device that received FDA 510(k) clearance on 2017-03-21. It is manufactured by Kico Knee Innovation Company Pty Limited. The 510(k) number is K163405.

When was 360KS Implant Positioning System approved by the FDA?

360KS Implant Positioning System received FDA 510(k) clearance on 2017-03-21, under approval number K163405.

What company makes 360KS Implant Positioning System?

360KS Implant Positioning System is manufactured by Kico Knee Innovation Company Pty Limited.

What is the FDA product code for 360KS Implant Positioning System?

The FDA product code for 360KS Implant Positioning System is LLZ.

Related Clinical Trials

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Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Kico Knee Innovation Company Pty Limited

K213380360CAS K223927360CAS K243980ARVIS Surgical Navigation System

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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