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FDA 510(k)

Paratrooper Plantar Plate Repair System

K-Number: K191227 · 2020-01-24

ApplicantParagon 28, Inc.
Decision Date2020-01-24
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Paratrooper Plantar Plate Repair 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 2020-01-24 under 510(k) number K191227. 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 Paratrooper Plantar Plate Repair System?

Paratrooper Plantar Plate Repair System is a medical device that received FDA 510(k) clearance on 2020-01-24. The listed applicant is Paragon 28, Inc.. The 510(k) number is K191227.

When did Paratrooper Plantar Plate Repair System receive FDA 510(k) clearance?

Paratrooper Plantar Plate Repair System received FDA 510(k) clearance on 2020-01-24, under 510(k) number K191227.

Who is the listed applicant for Paratrooper Plantar Plate Repair 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 Paratrooper Plantar Plate Repair System?

The FDA product code for Paratrooper Plantar Plate Repair 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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