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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 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 2019-01-11 under 510(k) 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. The listed applicant is Gramercy Extremity Orthopedics, LLC. The 510(k) number is K182212.

When did Geo Staple System receive FDA 510(k) clearance?

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

Who is the listed applicant for Geo Staple 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 Staple System?

The FDA product code for Geo Staple System is JDR.

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 SystemK210534GEO FirstFUSE 1st MTP Joint Arthrodesis Plating SystemK202817GEO Bone Screw SystemK200108GEO 1st MTP Joint Arthrodesis Plating System

Related Devices (Code: JDR)

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.

K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical ConceptsK242415TMC Compression Implant SystemTreace Medical Concepts

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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