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FDA 510(k)

Baby Gorilla/Gorilla Plating System; Monster Screw System

K-Number: K241262 · 2024-06-05

ApplicantParagon 28, Inc.
Decision Date2024-06-05
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Baby Gorilla/Gorilla Plating System; Monster Screw 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 2024-06-05 under 510(k) number K241262. 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; Monster Screw System?

Baby Gorilla/Gorilla Plating System; Monster Screw System is a medical device that received FDA 510(k) clearance on 2024-06-05. The listed applicant is Paragon 28, Inc.. The 510(k) number is K241262.

When did Baby Gorilla/Gorilla Plating System; Monster Screw System receive FDA 510(k) clearance?

Baby Gorilla/Gorilla Plating System; Monster Screw System received FDA 510(k) clearance on 2024-06-05, under 510(k) number K241262.

Who is the listed applicant for Baby Gorilla/Gorilla Plating System; Monster Screw 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; Monster Screw System?

The FDA product code for Baby Gorilla/Gorilla Plating System; Monster Screw System is HRS.

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Related Devices (Code: HRS)

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.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

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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