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FDA 510(k)

Maven Patient-Specific Instrumentation

K-Number: K202019 · 2021-01-14

ApplicantParagon 28, Inc.
Decision Date2021-01-14
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Maven Patient-Specific Instrumentation is a medical device manufactured by Paragon 28, Inc.. It received FDA 510(k) clearance on 2021-01-14 under approval number K202019. 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 2021-01-14. It is manufactured by Paragon 28, Inc.. The 510(k) number is K202019.

When was Maven Patient-Specific Instrumentation approved by the FDA?

Maven Patient-Specific Instrumentation received FDA 510(k) clearance on 2021-01-14, under approval number K202019.

What company makes Maven Patient-Specific Instrumentation?

Maven Patient-Specific Instrumentation is manufactured by Paragon 28, Inc..

What is the FDA product code for Maven Patient-Specific Instrumentation?

The FDA product code for Maven Patient-Specific Instrumentation is HSN.

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Related PubMed Literature

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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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