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FDA 510(k)

BONEOPTIMIZER

K-Number: K100841 · 2010-08-19

ApplicantCurasan AG
Decision Date2010-08-19
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BONEOPTIMIZER is the device name listed in this FDA 510(k) record. The listed applicant is Curasan AG. It received FDA 510(k) clearance on 2010-08-19 under 510(k) number K100841. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONEOPTIMIZER?

BONEOPTIMIZER is a medical device that received FDA 510(k) clearance on 2010-08-19. The listed applicant is Curasan AG. The 510(k) number is K100841.

When did BONEOPTIMIZER receive FDA 510(k) clearance?

BONEOPTIMIZER received FDA 510(k) clearance on 2010-08-19, under 510(k) number K100841.

Who is the listed applicant for BONEOPTIMIZER?

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

What is the FDA product code for BONEOPTIMIZER?

The FDA product code for BONEOPTIMIZER is MQV.

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Related Devices (Code: MQV)

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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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