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FDA 510(k)

POWEReam Xia/Serrato

K-Number: K240526 · 2024-04-29

ApplicantStryker Instruments
Decision Date2024-04-29
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

POWEReam Xia/Serrato is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Instruments. It received FDA 510(k) clearance on 2024-04-29 under 510(k) number K240526. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POWEReam Xia/Serrato?

POWEReam Xia/Serrato is a medical device that received FDA 510(k) clearance on 2024-04-29. The listed applicant is Stryker Instruments. The 510(k) number is K240526.

When did POWEReam Xia/Serrato receive FDA 510(k) clearance?

POWEReam Xia/Serrato received FDA 510(k) clearance on 2024-04-29, under 510(k) number K240526.

Who is the listed applicant for POWEReam Xia/Serrato?

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

What is the FDA product code for POWEReam Xia/Serrato?

The FDA product code for POWEReam Xia/Serrato is NKB.

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Related Devices (Code: NKB)

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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