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FDA 510(k)

POWEReam 1/4 Drive

K-Number: K233300 · 2023-12-26

ApplicantStryker Instruments
Decision Date2023-12-26
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

POWEReam 1/4 Drive is a medical device manufactured by Stryker Instruments. It received FDA 510(k) clearance on 2023-12-26 under approval number K233300. 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 1/4 Drive?

POWEReam 1/4 Drive is a medical device that received FDA 510(k) clearance on 2023-12-26. It is manufactured by Stryker Instruments. The 510(k) number is K233300.

When was POWEReam 1/4 Drive approved by the FDA?

POWEReam 1/4 Drive received FDA 510(k) clearance on 2023-12-26, under approval number K233300.

What company makes POWEReam 1/4 Drive?

POWEReam 1/4 Drive is manufactured by Stryker Instruments.

What is the FDA product code for POWEReam 1/4 Drive?

The FDA product code for POWEReam 1/4 Drive is NKB.

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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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