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FDA 510(k)

GEO Extremity and Ankle Plating System

K-Number: K212334 · 2021-09-21

ApplicantGramercy Extremity Orthopedics, LLC
Decision Date2021-09-21
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GEO Extremity and Ankle Plating System is a medical device manufactured by Gramercy Extremity Orthopedics, LLC. It received FDA 510(k) clearance on 2021-09-21 under approval number K212334. 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 Extremity and Ankle Plating System?

GEO Extremity and Ankle Plating System is a medical device that received FDA 510(k) clearance on 2021-09-21. It is manufactured by Gramercy Extremity Orthopedics, LLC. The 510(k) number is K212334.

When was GEO Extremity and Ankle Plating System approved by the FDA?

GEO Extremity and Ankle Plating System received FDA 510(k) clearance on 2021-09-21, under approval number K212334.

What company makes GEO Extremity and Ankle Plating System?

GEO Extremity and Ankle Plating System is manufactured by Gramercy Extremity Orthopedics, LLC.

What is the FDA product code for GEO Extremity and Ankle Plating System?

The FDA product code for GEO Extremity and Ankle 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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