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FDA 510(k)

STRYKER UNIVERSAL NEURO 3 SYSTEM

K-Number: K112557 · 2012-01-05

ApplicantStryker
Decision Date2012-01-05
Product CodeGWO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STRYKER 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 2012-01-05 under 510(k) number K112557. 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 STRYKER UNIVERSAL NEURO 3 SYSTEM?

STRYKER UNIVERSAL NEURO 3 SYSTEM is a medical device that received FDA 510(k) clearance on 2012-01-05. The listed applicant is Stryker. The 510(k) number is K112557.

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

STRYKER UNIVERSAL NEURO 3 SYSTEM received FDA 510(k) clearance on 2012-01-05, under 510(k) number K112557.

Who is the listed applicant for STRYKER 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 STRYKER UNIVERSAL NEURO 3 SYSTEM?

The FDA product code for STRYKER 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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