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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 a medical device manufactured by Stryker Instruments. It received FDA 510(k) clearance on 2024-04-29 under approval 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. It is manufactured by Stryker Instruments. The 510(k) number is K240526.

When was POWEReam Xia/Serrato approved by the FDA?

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

What company makes POWEReam Xia/Serrato?

POWEReam Xia/Serrato is manufactured by Stryker Instruments.

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

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

Other Devices by Stryker Instruments

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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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