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FDA 510(k)

Stryker Universal Neuro III System AXS Screw

K-Number: K171152 · 2017-05-19

ApplicantStryker
Decision Date2017-05-19
Product CodeHBW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Stryker Universal Neuro III System AXS Screw is the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2017-05-19 under 510(k) number K171152. The device is classified under product code HBW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stryker Universal Neuro III System AXS Screw?

Stryker Universal Neuro III System AXS Screw is a medical device that received FDA 510(k) clearance on 2017-05-19. The listed applicant is Stryker. The 510(k) number is K171152.

When did Stryker Universal Neuro III System AXS Screw receive FDA 510(k) clearance?

Stryker Universal Neuro III System AXS Screw received FDA 510(k) clearance on 2017-05-19, under 510(k) number K171152.

Who is the listed applicant for Stryker Universal Neuro III System AXS Screw?

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 III System AXS Screw?

The FDA product code for Stryker Universal Neuro III System AXS Screw is HBW.

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Related Devices (Code: HBW)

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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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