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FDA 510(k)

Stryker All-PEEK Knotless Anchor System

K-Number: K181083 · 2018-07-23

ApplicantStryker
Decision Date2018-07-23
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Stryker All-PEEK Knotless Anchor System is a medical device manufactured by Stryker. It received FDA 510(k) clearance on 2018-07-23 under approval number K181083. 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 Stryker All-PEEK Knotless Anchor System?

Stryker All-PEEK Knotless Anchor System is a medical device that received FDA 510(k) clearance on 2018-07-23. It is manufactured by Stryker. The 510(k) number is K181083.

When was Stryker All-PEEK Knotless Anchor System approved by the FDA?

Stryker All-PEEK Knotless Anchor System received FDA 510(k) clearance on 2018-07-23, under approval number K181083.

What company makes Stryker All-PEEK Knotless Anchor System?

Stryker All-PEEK Knotless Anchor System is manufactured by Stryker.

What is the FDA product code for Stryker All-PEEK Knotless Anchor System?

The FDA product code for Stryker All-PEEK Knotless Anchor System is MBI.

Related Clinical Trials

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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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