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FDA 510(k)

Stryker Upper-Face AXS screws and Mid-Face AXS screws

K-Number: K172572 · 2017-10-31

ApplicantStryker
Decision Date2017-10-31
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Stryker Upper-Face AXS screws and Mid-Face AXS screws is a medical device manufactured by Stryker. It received FDA 510(k) clearance on 2017-10-31 under approval number K172572. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stryker Upper-Face AXS screws and Mid-Face AXS screws?

Stryker Upper-Face AXS screws and Mid-Face AXS screws is a medical device that received FDA 510(k) clearance on 2017-10-31. It is manufactured by Stryker. The 510(k) number is K172572.

When was Stryker Upper-Face AXS screws and Mid-Face AXS screws approved by the FDA?

Stryker Upper-Face AXS screws and Mid-Face AXS screws received FDA 510(k) clearance on 2017-10-31, under approval number K172572.

What company makes Stryker Upper-Face AXS screws and Mid-Face AXS screws?

Stryker Upper-Face AXS screws and Mid-Face AXS screws is manufactured by Stryker.

What is the FDA product code for Stryker Upper-Face AXS screws and Mid-Face AXS screws?

The FDA product code for Stryker Upper-Face AXS screws and Mid-Face AXS screws is JEY.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.