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FDA 510(k)

Stryker AlphaVent™ Knotless SP Biocomposite Anchor

K-Number: K250528 · 2025-05-21

ApplicantStryker Endoscopy
Decision Date2025-05-21
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Stryker AlphaVent™ Knotless SP Biocomposite Anchor is a medical device manufactured by Stryker Endoscopy. It received FDA 510(k) clearance on 2025-05-21 under approval number K250528. 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 Stryker AlphaVent™ Knotless SP Biocomposite Anchor?

Stryker AlphaVent™ Knotless SP Biocomposite Anchor is a medical device that received FDA 510(k) clearance on 2025-05-21. It is manufactured by Stryker Endoscopy. The 510(k) number is K250528.

When was Stryker AlphaVent™ Knotless SP Biocomposite Anchor approved by the FDA?

Stryker AlphaVent™ Knotless SP Biocomposite Anchor received FDA 510(k) clearance on 2025-05-21, under approval number K250528.

What company makes Stryker AlphaVent™ Knotless SP Biocomposite Anchor?

Stryker AlphaVent™ Knotless SP Biocomposite Anchor is manufactured by Stryker Endoscopy.

What is the FDA product code for Stryker AlphaVent™ Knotless SP Biocomposite Anchor?

The FDA product code for Stryker AlphaVent™ Knotless SP Biocomposite Anchor is MAI.

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K161174Nanova Interference ScrewNanova Biomaterials, Inc. K160804INTRAFIX(TM) Advance Tibial Fastener SystemMedos International SARL K151342Arthrex SwiveLock AnchorsArthrex, Inc. K170868FIXIT Threaded Anchor SystemS.B.M Sas Science For Bio Materials K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL K171592CrossFT™ Knotless Biocomposite Suture Anchor with Disposable DriverConmed 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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