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FDA 510(k)

Paragon 28 APEX 3D Total Ankle Replacement System

K-Number: K192994 · 2020-07-10

ApplicantParagon 28, Inc.
Decision Date2020-07-10
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Paragon 28 APEX 3D Total Ankle Replacement System is a medical device manufactured by Paragon 28, Inc.. It received FDA 510(k) clearance on 2020-07-10 under approval number K192994. The device is classified under product code HSN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Paragon 28 APEX 3D Total Ankle Replacement System?

Paragon 28 APEX 3D Total Ankle Replacement System is a medical device that received FDA 510(k) clearance on 2020-07-10. It is manufactured by Paragon 28, Inc.. The 510(k) number is K192994.

When was Paragon 28 APEX 3D Total Ankle Replacement System approved by the FDA?

Paragon 28 APEX 3D Total Ankle Replacement System received FDA 510(k) clearance on 2020-07-10, under approval number K192994.

What company makes Paragon 28 APEX 3D Total Ankle Replacement System?

Paragon 28 APEX 3D Total Ankle Replacement System is manufactured by Paragon 28, Inc..

What is the FDA product code for Paragon 28 APEX 3D Total Ankle Replacement System?

The FDA product code for Paragon 28 APEX 3D Total Ankle Replacement System is HSN.

Related Clinical Trials

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41460256 Benchmarking THA Implant Combinations Using Data From a US Total Joint Replacement Registry. Clinical orthopaedics and related research (2026)

Other Devices by Paragon 28, Inc.

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Related Devices (Code: HSN)

K153452Salto XT, Salto TalarisTornier S.A.S. K153008INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc K152217Exactech Vantage Total Ankle SystemExactech, Inc. K171004Hintermann Series H2 Total Ankle SystemDt Medtech, LLC K171067INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc K170968PROPHECY INVISION Pre-operative Navigation SystemWrightmedicaltechnologyinc

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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