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FDA 510(k)

GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System

K-Number: K210534 · 2021-03-26

ApplicantGramercy Extremity Orthopedics, LLC
Decision Date2021-03-26
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Gramercy Extremity Orthopedics, LLC. It received FDA 510(k) clearance on 2021-03-26 under 510(k) number K210534. 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 GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System?

GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System is a medical device that received FDA 510(k) clearance on 2021-03-26. The listed applicant is Gramercy Extremity Orthopedics, LLC. The 510(k) number is K210534.

When did GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System receive FDA 510(k) clearance?

GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System received FDA 510(k) clearance on 2021-03-26, under 510(k) number K210534.

Who is the listed applicant for GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System?

The FDA 510(k) record lists Gramercy Extremity Orthopedics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System?

The FDA product code for GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System is HRS.

Other records listing Gramercy Extremity Orthopedics, LLC as applicant

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.

K212334GEO Extremity and Ankle Plating SystemK202817GEO Bone Screw SystemK200108GEO 1st MTP Joint Arthrodesis Plating SystemK182212Geo Staple System

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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