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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 the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2017-10-31 under 510(k) 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. The listed applicant is Stryker. The 510(k) number is K172572.

When did Stryker Upper-Face AXS screws and Mid-Face AXS screws receive FDA 510(k) clearance?

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

Who is the listed applicant for Stryker Upper-Face AXS screws and Mid-Face AXS screws?

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 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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07245719Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow UpCOMPLETED

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Related Devices (Code: JEY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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