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FDA 510(k)

FITBONE(R) TAA

K-Number: K203399 · 2021-02-17

ApplicantWittenstein Intens GmbH
Decision Date2021-02-17
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FITBONE(R) TAA is a medical device manufactured by Wittenstein Intens GmbH. It received FDA 510(k) clearance on 2021-02-17 under approval number K203399. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FITBONE(R) TAA?

FITBONE(R) TAA is a medical device that received FDA 510(k) clearance on 2021-02-17. It is manufactured by Wittenstein Intens GmbH. The 510(k) number is K203399.

When was FITBONE(R) TAA approved by the FDA?

FITBONE(R) TAA received FDA 510(k) clearance on 2021-02-17, under approval number K203399.

What company makes FITBONE(R) TAA?

FITBONE(R) TAA is manufactured by Wittenstein Intens GmbH.

What is the FDA product code for FITBONE(R) TAA?

The FDA product code for FITBONE(R) TAA is HSB.

Other Devices by Wittenstein Intens GmbH

K163368FITBONE TAA

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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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