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FDA 510(k)

Orthofix MJ-FLEX THE NEW METAIZEAU NAIL

K-Number: K173051 · 2017-11-16

ApplicantOrthofix Srl
Decision Date2017-11-16
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Orthofix MJ-FLEX THE NEW METAIZEAU NAIL is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix Srl. It received FDA 510(k) clearance on 2017-11-16 under 510(k) number K173051. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Orthofix MJ-FLEX THE NEW METAIZEAU NAIL?

Orthofix MJ-FLEX THE NEW METAIZEAU NAIL is a medical device that received FDA 510(k) clearance on 2017-11-16. The listed applicant is Orthofix Srl. The 510(k) number is K173051.

When did Orthofix MJ-FLEX THE NEW METAIZEAU NAIL receive FDA 510(k) clearance?

Orthofix MJ-FLEX THE NEW METAIZEAU NAIL received FDA 510(k) clearance on 2017-11-16, under 510(k) number K173051.

Who is the listed applicant for Orthofix MJ-FLEX THE NEW METAIZEAU NAIL?

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

What is the FDA product code for Orthofix MJ-FLEX THE NEW METAIZEAU NAIL?

The FDA product code for Orthofix MJ-FLEX THE NEW METAIZEAU NAIL is HTY.

Other records listing Orthofix Srl as applicant

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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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