FDA 510(k)

Arthrex SpeedFLEX Implant

K-Number: K251690 · 2025-09-30

Decision Date2025-09-30

Product CodeOWY

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Arthrex SpeedFLEX Implant is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2025-09-30 under approval number K251690. The device is classified under product code OWY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex SpeedFLEX Implant?

Arthrex SpeedFLEX Implant is a medical device that received FDA 510(k) clearance on 2025-09-30. It is manufactured by Arthrex, Inc.. The 510(k) number is K251690.

When was Arthrex SpeedFLEX Implant approved by the FDA?

Arthrex SpeedFLEX Implant received FDA 510(k) clearance on 2025-09-30, under approval number K251690.

What company makes Arthrex SpeedFLEX Implant?

Arthrex SpeedFLEX Implant is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex SpeedFLEX Implant?

The FDA product code for Arthrex SpeedFLEX Implant is OWY.

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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.