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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 the device name listed in this FDA 510(k) record. The listed applicant is Paragon 28, Inc.. It received FDA 510(k) clearance on 2025-07-18 under 510(k) 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. The listed applicant is Paragon 28, Inc.. The 510(k) number is K250952.

When did Baby Gorilla®/Gorilla® Plating System receive FDA 510(k) clearance?

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

Who is the listed applicant for Baby Gorilla®/Gorilla® Plating 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 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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