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FDA 510(k)

Knotilus+ PEEK Knotless Anchor

K-Number: K232683 · 2023-10-24

ApplicantStryker Endoscopy
Decision Date2023-10-24
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Knotilus+ PEEK Knotless Anchor is a medical device manufactured by Stryker Endoscopy. It received FDA 510(k) clearance on 2023-10-24 under approval number K232683. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Knotilus+ PEEK Knotless Anchor?

Knotilus+ PEEK Knotless Anchor is a medical device that received FDA 510(k) clearance on 2023-10-24. It is manufactured by Stryker Endoscopy. The 510(k) number is K232683.

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

Knotilus+ PEEK Knotless Anchor received FDA 510(k) clearance on 2023-10-24, under approval number K232683.

What company makes Knotilus+ PEEK Knotless Anchor?

Knotilus+ PEEK Knotless Anchor is manufactured by Stryker Endoscopy.

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

The FDA product code for Knotilus+ PEEK Knotless Anchor is MBI.

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Related Devices (Code: MBI)

K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc. K162198GFS UltimateParcus Medical, LLC K162386KATOR Suture AnchorKator, LLC K161033AFX™ Femoral Implant With InserterCayenne Medical, Inc. K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL

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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