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FDA 510(k)

LIGAMENTOTAXOR

K-Number: K094043 · 2010-08-17

ApplicantArex USA
Decision Date2010-08-17
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LIGAMENTOTAXOR is the device name listed in this FDA 510(k) record. The listed applicant is Arex USA. It received FDA 510(k) clearance on 2010-08-17 under 510(k) number K094043. 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 LIGAMENTOTAXOR?

LIGAMENTOTAXOR is a medical device that received FDA 510(k) clearance on 2010-08-17. The listed applicant is Arex USA. The 510(k) number is K094043.

When did LIGAMENTOTAXOR receive FDA 510(k) clearance?

LIGAMENTOTAXOR received FDA 510(k) clearance on 2010-08-17, under 510(k) number K094043.

Who is the listed applicant for LIGAMENTOTAXOR?

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

What is the FDA product code for LIGAMENTOTAXOR?

The FDA product code for LIGAMENTOTAXOR is HTY.

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Other records listing Arex USA as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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