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FDA 510(k)

Spine & Trauma Navigation Instruments

K-Number: K252562 · 2025-09-12

ApplicantBrainlab AG
Decision Date2025-09-12
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Spine & Trauma Navigation Instruments is a medical device manufactured by Brainlab AG. It received FDA 510(k) clearance on 2025-09-12 under approval number K252562. 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 Spine & Trauma Navigation Instruments?

Spine & Trauma Navigation Instruments is a medical device that received FDA 510(k) clearance on 2025-09-12. It is manufactured by Brainlab AG. The 510(k) number is K252562.

When was Spine & Trauma Navigation Instruments approved by the FDA?

Spine & Trauma Navigation Instruments received FDA 510(k) clearance on 2025-09-12, under approval number K252562.

What company makes Spine & Trauma Navigation Instruments?

Spine & Trauma Navigation Instruments is manufactured by Brainlab AG.

What is the FDA product code for Spine & Trauma Navigation Instruments?

The FDA product code for Spine & Trauma Navigation Instruments is OLO.

Related Clinical Trials

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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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