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FDA 510(k)

GEO 1st MTP Joint Arthrodesis Plating System

K-Number: K200108 · 2020-03-26

ApplicantGramercy Extremity Orthopedics, LLC
Decision Date2020-03-26
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GEO 1st MTP Joint Arthrodesis Plating System is a medical device manufactured by Gramercy Extremity Orthopedics, LLC. It received FDA 510(k) clearance on 2020-03-26 under approval number K200108. 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 1st MTP Joint Arthrodesis Plating System?

GEO 1st MTP Joint Arthrodesis Plating System is a medical device that received FDA 510(k) clearance on 2020-03-26. It is manufactured by Gramercy Extremity Orthopedics, LLC. The 510(k) number is K200108.

When was GEO 1st MTP Joint Arthrodesis Plating System approved by the FDA?

GEO 1st MTP Joint Arthrodesis Plating System received FDA 510(k) clearance on 2020-03-26, under approval number K200108.

What company makes GEO 1st MTP Joint Arthrodesis Plating System?

GEO 1st MTP Joint Arthrodesis Plating System is manufactured by Gramercy Extremity Orthopedics, LLC.

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

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

Related Clinical Trials

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Other Devices by Gramercy Extremity Orthopedics, LLC

K182212Geo Staple System K202817GEO Bone Screw System K212334GEO Extremity and Ankle Plating System K210534GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System

Related Devices (Code: 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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