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FDA 510(k)

ARTHREX FRACTURE SYSTEM

K-Number: K112437 · 2011-12-21

ApplicantArthrex, Inc.
Decision Date2011-12-21
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARTHREX FRACTURE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2011-12-21 under 510(k) number K112437. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTHREX FRACTURE SYSTEM?

ARTHREX FRACTURE SYSTEM is a medical device that received FDA 510(k) clearance on 2011-12-21. The listed applicant is Arthrex, Inc.. The 510(k) number is K112437.

When did ARTHREX FRACTURE SYSTEM receive FDA 510(k) clearance?

ARTHREX FRACTURE SYSTEM received FDA 510(k) clearance on 2011-12-21, under 510(k) number K112437.

Who is the listed applicant for ARTHREX FRACTURE SYSTEM?

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

What is the FDA product code for ARTHREX FRACTURE SYSTEM?

The FDA product code for ARTHREX FRACTURE SYSTEM is HTN.

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Related Devices (Code: HTN)

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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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