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FDA 510(k)

BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B

K-Number: K043145 · 2005-02-18

ApplicantArthrex, Inc.
Decision Date2005-02-18
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2005-02-18 under 510(k) number K043145. 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 BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B?

BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B is a medical device that received FDA 510(k) clearance on 2005-02-18. The listed applicant is Arthrex, Inc.. The 510(k) number is K043145.

When did BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B receive FDA 510(k) clearance?

BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B received FDA 510(k) clearance on 2005-02-18, under 510(k) number K043145.

Who is the listed applicant for BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B?

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 BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B?

The FDA product code for BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B is 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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