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FDA 510(k)

Baby Gorilla®/Gorilla® Plating System

K-Number: K250952 · 2025-07-18

ApplicantParagon 28, Inc.
Decision Date2025-07-18
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Baby Gorilla®/Gorilla® Plating System is a medical device manufactured by Paragon 28, Inc.. It received FDA 510(k) clearance on 2025-07-18 under approval number K250952. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Baby Gorilla®/Gorilla® Plating System?

Baby Gorilla®/Gorilla® Plating System is a medical device that received FDA 510(k) clearance on 2025-07-18. It is manufactured by Paragon 28, Inc.. The 510(k) number is K250952.

When was Baby Gorilla®/Gorilla® Plating System approved by the FDA?

Baby Gorilla®/Gorilla® Plating System received FDA 510(k) clearance on 2025-07-18, under approval number K250952.

What company makes Baby Gorilla®/Gorilla® Plating System?

Baby Gorilla®/Gorilla® Plating System is manufactured by Paragon 28, Inc..

What is the FDA product code for Baby Gorilla®/Gorilla® Plating System?

The FDA product code for Baby Gorilla®/Gorilla® Plating System is HRS.

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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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