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FDA 510(k)

Cirq Arm System (2.0);Alignment System Spine

K-Number: K222966 · 2022-10-27

ApplicantBrainlab AG
Decision Date2022-10-27
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Cirq Arm System (2.0);Alignment System Spine is a medical device manufactured by Brainlab AG. It received FDA 510(k) clearance on 2022-10-27 under approval number K222966. 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 Cirq Arm System (2.0);Alignment System Spine?

Cirq Arm System (2.0);Alignment System Spine is a medical device that received FDA 510(k) clearance on 2022-10-27. It is manufactured by Brainlab AG. The 510(k) number is K222966.

When was Cirq Arm System (2.0);Alignment System Spine approved by the FDA?

Cirq Arm System (2.0);Alignment System Spine received FDA 510(k) clearance on 2022-10-27, under approval number K222966.

What company makes Cirq Arm System (2.0);Alignment System Spine?

Cirq Arm System (2.0);Alignment System Spine is manufactured by Brainlab AG.

What is the FDA product code for Cirq Arm System (2.0);Alignment System Spine?

The FDA product code for Cirq Arm System (2.0);Alignment System Spine is OLO.

Related Clinical Trials

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Related PubMed Literature

PMID: 36074993 Reported Events Associated With Spine Robots: An Analysis of the Food and Drug Administration's Manufacturer and User Facility Device Experience Database. Global spine journal (2023)

Other Devices by Brainlab AG

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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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