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FDA 510(k)

Geo Staple System

K-Number: K182212 · 2019-01-11

ApplicantGramercy Extremity Orthopedics, LLC
Decision Date2019-01-11
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Geo Staple System is a medical device manufactured by Gramercy Extremity Orthopedics, LLC. It received FDA 510(k) clearance on 2019-01-11 under approval number K182212. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Geo Staple System?

Geo Staple System is a medical device that received FDA 510(k) clearance on 2019-01-11. It is manufactured by Gramercy Extremity Orthopedics, LLC. The 510(k) number is K182212.

When was Geo Staple System approved by the FDA?

Geo Staple System received FDA 510(k) clearance on 2019-01-11, under approval number K182212.

What company makes Geo Staple System?

Geo Staple System is manufactured by Gramercy Extremity Orthopedics, LLC.

What is the FDA product code for Geo Staple System?

The FDA product code for Geo Staple System is JDR.

Other Devices by Gramercy Extremity Orthopedics, LLC

K202817GEO Bone Screw System K200108GEO 1st MTP Joint Arthrodesis Plating System K212334GEO Extremity and Ankle Plating System K210534GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System

Related Devices (Code: JDR)

K161426NeoSpan Compression Staple Impant w/instrumentsIn2bones USA, LLC K160813EasyStepStryker GmbH K153622First Ray Internal Bone Staple SystemFirst Ray, LLC K153770OS2(R)-VP Varisation StapleIn2bones Sas K153395OS2-C Compression StapleIn2bones Sas K153129dynaMX Tabbed StapleMx Orthopedics, Corp.

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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