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FDA 510(k)

Arthrex FastThread Interference Screw

K-Number: K202535 · 2020-11-18

ApplicantArthrex, Inc.
Decision Date2020-11-18
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex FastThread Interference Screw is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2020-11-18 under 510(k) number K202535. 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 FastThread Interference Screw?

Arthrex FastThread Interference Screw is a medical device that received FDA 510(k) clearance on 2020-11-18. The listed applicant is Arthrex, Inc.. The 510(k) number is K202535.

When did Arthrex FastThread Interference Screw receive FDA 510(k) clearance?

Arthrex FastThread Interference Screw received FDA 510(k) clearance on 2020-11-18, under 510(k) number K202535.

Who is the listed applicant for Arthrex FastThread Interference Screw?

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 FastThread Interference Screw?

The FDA product code for Arthrex FastThread Interference Screw is MAI.

Other records listing Arthrex, Inc. as applicant

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.

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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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