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FDA 510(k)

Stryker Omega PEEK Knotless Anchor System

K-Number: K202355 · 2020-11-13

ApplicantStryker
Decision Date2020-11-13
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Stryker Omega PEEK Knotless Anchor System is a medical device manufactured by Stryker. It received FDA 510(k) clearance on 2020-11-13 under approval number K202355. 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 Omega PEEK Knotless Anchor System?

Stryker Omega PEEK Knotless Anchor System is a medical device that received FDA 510(k) clearance on 2020-11-13. It is manufactured by Stryker. The 510(k) number is K202355.

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

Stryker Omega PEEK Knotless Anchor System received FDA 510(k) clearance on 2020-11-13, under approval number K202355.

What company makes Stryker Omega PEEK Knotless Anchor System?

Stryker Omega PEEK Knotless Anchor System is manufactured by Stryker.

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

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

Related Clinical Trials

NCT05362370 Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness ACTIVE_NOT_RECRUITING NCT07581977 A Novel Two-Tooth Clip for ESD and EFTR of GIST RECRUITING NCT07587593 The IVCare Adaptive Platform Trial NOT_YET_RECRUITING NCT06941558 The UK ADAPTIS Study ACTIVE_NOT_RECRUITING NCT07245758 Facial iD Customized Mandible Reconstruction Plates COMPLETED NCT07245719 Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up COMPLETED

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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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