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FDA 510(k)

360CAS

K-Number: K213380 · 2022-01-11

ApplicantKico Knee Innovation Company Pty Limited
Decision Date2022-01-11
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

360CAS is the device name listed in this FDA 510(k) record. The listed applicant is Kico Knee Innovation Company Pty Limited. It received FDA 510(k) clearance on 2022-01-11 under 510(k) number K213380. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 360CAS?

360CAS is a medical device that received FDA 510(k) clearance on 2022-01-11. The listed applicant is Kico Knee Innovation Company Pty Limited. The 510(k) number is K213380.

When did 360CAS receive FDA 510(k) clearance?

360CAS received FDA 510(k) clearance on 2022-01-11, under 510(k) number K213380.

Who is the listed applicant for 360CAS?

The FDA 510(k) record lists Kico Knee Innovation Company Pty Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 360CAS?

The FDA product code for 360CAS is OLO.

Other records listing Kico Knee Innovation Company Pty Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243980ARVIS Surgical Navigation SystemK243950ARVIS® ShoulderK242009360CAS KneeK223927360CASK163405360KS Implant Positioning System

Related Devices (Code: OLO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation CentreK261205SPINEART Navigation Instrument SystemSpineart SAK262121Ion-L Navigated InstrumentsSurGenTec, LLCK261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K261113Op.n™ Spine Navigation and Robotic GuidanceEcential RoboticsK261852OTS HipOrtoma AB

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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