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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 the device name listed in this FDA 510(k) record. The listed applicant is Paragon 28, Inc.. It received FDA 510(k) clearance on 2020-07-10 under 510(k) 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. The listed applicant is Paragon 28, Inc.. The 510(k) number is K192994.

When did Paragon 28 APEX 3D Total Ankle Replacement System receive FDA 510(k) clearance?

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

Who is the listed applicant for Paragon 28 APEX 3D Total Ankle Replacement 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 Paragon 28 APEX 3D Total Ankle Replacement System?

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

Other records listing Paragon 28, Inc. as applicant

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Related Devices (Code: HSN)

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.

K253159Prophecy Incompass Surgical Planning SystemWright Medical Technology, Inc. (Stryker)K252454Kinos Total Ankle SystemRestor3DK250037Incompass Total Ankle SystemWright Medical Technology, Inc. (Stryker)K250641APEX 3D Total Ankle Replacement SystemParagon 28, Inc.K240475Hintermann Series H2 Total Ankle SystemVilex, LLCK241999Prophecy Surgical Planning SystemWright Medical Technology, Inc. (Stryker)

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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