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FDA 510(k)

ARTHREX BIO-POST AND WASHER

K-Number: K011495 · 2001-08-01

ApplicantArthrex, Inc.
Decision Date2001-08-01
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARTHREX BIO-POST AND WASHER is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2001-08-01 under 510(k) number K011495. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTHREX BIO-POST AND WASHER?

ARTHREX BIO-POST AND WASHER is a medical device that received FDA 510(k) clearance on 2001-08-01. The listed applicant is Arthrex, Inc.. The 510(k) number is K011495.

When did ARTHREX BIO-POST AND WASHER receive FDA 510(k) clearance?

ARTHREX BIO-POST AND WASHER received FDA 510(k) clearance on 2001-08-01, under 510(k) number K011495.

Who is the listed applicant for ARTHREX BIO-POST AND WASHER?

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-POST AND WASHER?

The FDA product code for ARTHREX BIO-POST AND WASHER is MAI.

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Other records listing Arthrex, Inc. as applicant

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Related Devices (Code: MAI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.K260294SF Push-in AnchorSurgical Fusion Technologies GmbHK254055OSSIOfiber® Suture AnchorOSSIO , Ltd.K251680Biosteon® ScrewBiocomposites, Ltd.K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation

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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