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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 the device name listed in this FDA 510(k) record. The listed applicant is Stryker Endoscopy. It received FDA 510(k) clearance on 2025-05-21 under 510(k) 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. The listed applicant is Stryker Endoscopy. The 510(k) number is K250528.

When did Stryker AlphaVent™ Knotless SP Biocomposite Anchor receive FDA 510(k) clearance?

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

Who is the listed applicant for Stryker AlphaVent™ Knotless SP Biocomposite Anchor?

The FDA 510(k) record lists Stryker Endoscopy as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

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.

NCT07631468PROspect Registry :Post Market Clinical Follow-up StudyNOT_YET_RECRUITING

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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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