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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 a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2020-11-18 under approval 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. It is manufactured by Arthrex, Inc.. The 510(k) number is K202535.

When was Arthrex FastThread Interference Screw approved by the FDA?

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

What company makes Arthrex FastThread Interference Screw?

Arthrex FastThread Interference Screw is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex FastThread Interference Screw?

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

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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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