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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 the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2020-11-13 under 510(k) 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. The listed applicant is Stryker. The 510(k) number is K202355.

When did Stryker Omega PEEK Knotless Anchor System receive FDA 510(k) clearance?

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

Who is the listed applicant for Stryker Omega PEEK Knotless Anchor System?

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

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

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.

NCT05362370Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and EffectivenessACTIVE_NOT_RECRUITING

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Related Devices (Code: MBI)

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.

K262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker EndoscopyK261770Suture Button Repair SystemSkeletal Dynamics, Inc.K261632Thunderbolt SystemResponsive Arthroscopy, Inc.K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)Smith & Nephew, Inc.K260018Arthrex FiberButtonArthrex, Inc.

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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