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FDA 510(k)

MAVEN™ Patient-Specific Instrumentation

K-Number: K223227 · 2022-11-17

ApplicantParagon 28, Inc.
Decision Date2022-11-17
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MAVEN™ Patient-Specific Instrumentation 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 2022-11-17 under 510(k) number K223227. 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 MAVEN™ Patient-Specific Instrumentation?

MAVEN™ Patient-Specific Instrumentation is a medical device that received FDA 510(k) clearance on 2022-11-17. The listed applicant is Paragon 28, Inc.. The 510(k) number is K223227.

When did MAVEN™ Patient-Specific Instrumentation receive FDA 510(k) clearance?

MAVEN™ Patient-Specific Instrumentation received FDA 510(k) clearance on 2022-11-17, under 510(k) number K223227.

Who is the listed applicant for MAVEN™ Patient-Specific Instrumentation?

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 MAVEN™ Patient-Specific Instrumentation?

The FDA product code for MAVEN™ Patient-Specific Instrumentation 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.

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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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