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FDA 510(k)

UNIVERSAL NEURO 3 SYSTEM

K-Number: K131775 · 2013-10-17

ApplicantStryker
Decision Date2013-10-17
Product CodeGWO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL NEURO 3 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2013-10-17 under 510(k) number K131775. The device is classified under product code GWO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIVERSAL NEURO 3 SYSTEM?

UNIVERSAL NEURO 3 SYSTEM is a medical device that received FDA 510(k) clearance on 2013-10-17. The listed applicant is Stryker. The 510(k) number is K131775.

When did UNIVERSAL NEURO 3 SYSTEM receive FDA 510(k) clearance?

UNIVERSAL NEURO 3 SYSTEM received FDA 510(k) clearance on 2013-10-17, under 510(k) number K131775.

Who is the listed applicant for UNIVERSAL NEURO 3 SYSTEM?

The FDA 510(k) record lists Stryker as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNIVERSAL NEURO 3 SYSTEM?

The FDA product code for UNIVERSAL NEURO 3 SYSTEM is GWO.

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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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