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FDA 510(k)

STAGE

K-Number: K210843 · 2021-06-29

ApplicantSpintech, Inc.
Decision Date2021-06-29
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

STAGE is a medical device manufactured by Spintech, Inc.. It received FDA 510(k) clearance on 2021-06-29 under approval number K210843. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAGE?

STAGE is a medical device that received FDA 510(k) clearance on 2021-06-29. It is manufactured by Spintech, Inc.. The 510(k) number is K210843.

When was STAGE approved by the FDA?

STAGE received FDA 510(k) clearance on 2021-06-29, under approval number K210843.

What company makes STAGE?

STAGE is manufactured by Spintech, Inc..

What is the FDA product code for STAGE?

The FDA product code for STAGE is LNH.

Other Devices by Spintech, Inc.

K173224SPIN-SWI K223079Stage

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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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