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FDA 510(k)

ARTHREX BIO-PIN

K-Number: K050259 · 2005-05-27

ApplicantArthrex, Inc.
Decision Date2005-05-27
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARTHREX BIO-PIN is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2005-05-27 under 510(k) number K050259. 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 ARTHREX BIO-PIN?

ARTHREX BIO-PIN is a medical device that received FDA 510(k) clearance on 2005-05-27. The listed applicant is Arthrex, Inc.. The 510(k) number is K050259.

When did ARTHREX BIO-PIN receive FDA 510(k) clearance?

ARTHREX BIO-PIN received FDA 510(k) clearance on 2005-05-27, under 510(k) number K050259.

Who is the listed applicant for ARTHREX BIO-PIN?

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 BIO-PIN?

The FDA product code for ARTHREX BIO-PIN is HTY.

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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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