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FDA 510(k)

Knotilus+ Biocomposite Knotless Anchor

K-Number: K250544 · 2025-05-23

ApplicantStryker Endoscopy
Decision Date2025-05-23
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Knotilus+ Biocomposite Knotless Anchor is a medical device manufactured by Stryker Endoscopy. It received FDA 510(k) clearance on 2025-05-23 under approval number K250544. 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 Knotilus+ Biocomposite Knotless Anchor?

Knotilus+ Biocomposite Knotless Anchor is a medical device that received FDA 510(k) clearance on 2025-05-23. It is manufactured by Stryker Endoscopy. The 510(k) number is K250544.

When was Knotilus+ Biocomposite Knotless Anchor approved by the FDA?

Knotilus+ Biocomposite Knotless Anchor received FDA 510(k) clearance on 2025-05-23, under approval number K250544.

What company makes Knotilus+ Biocomposite Knotless Anchor?

Knotilus+ Biocomposite Knotless Anchor is manufactured by Stryker Endoscopy.

What is the FDA product code for Knotilus+ Biocomposite Knotless Anchor?

The FDA product code for Knotilus+ Biocomposite Knotless Anchor 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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