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FDA 510(k)

Tenodesis Screw System

K-Number: K183690 · 2019-03-01

ApplicantParagon 28, Inc.
Decision Date2019-03-01
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tenodesis Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Paragon 28, Inc.. It received FDA 510(k) clearance on 2019-03-01 under 510(k) number K183690. 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 Tenodesis Screw System?

Tenodesis Screw System is a medical device that received FDA 510(k) clearance on 2019-03-01. The listed applicant is Paragon 28, Inc.. The 510(k) number is K183690.

When did Tenodesis Screw System receive FDA 510(k) clearance?

Tenodesis Screw System received FDA 510(k) clearance on 2019-03-01, under 510(k) number K183690.

Who is the listed applicant for Tenodesis Screw System?

The FDA 510(k) record lists Paragon 28, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tenodesis Screw System?

The FDA product code for Tenodesis Screw System is MBI.

Other records listing Paragon 28, Inc. as applicant

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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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