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FDA 510(k)

Spine & Trauma Navigation

K-Number: K191285 · 2019-06-11

ApplicantBrainlab AG
Decision Date2019-06-11
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Spine & Trauma Navigation is a medical device manufactured by Brainlab AG. It received FDA 510(k) clearance on 2019-06-11 under approval number K191285. 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?

Spine & Trauma Navigation is a medical device that received FDA 510(k) clearance on 2019-06-11. It is manufactured by Brainlab AG. The 510(k) number is K191285.

When was Spine & Trauma Navigation approved by the FDA?

Spine & Trauma Navigation received FDA 510(k) clearance on 2019-06-11, under approval number K191285.

What company makes Spine & Trauma Navigation?

Spine & Trauma Navigation is manufactured by Brainlab AG.

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

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

Related Clinical Trials

NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED

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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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