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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 a medical device manufactured by Gramercy Extremity Orthopedics, LLC. It received FDA 510(k) clearance on 2021-03-26 under approval 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. It is manufactured by Gramercy Extremity Orthopedics, LLC. The 510(k) number is K210534.

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

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

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

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

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.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07575750 Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Aromatase Inhibitor-induced Arthralgia (AIA) NOT_YET_RECRUITING NCT07598604 Early Mobilization and Equinus Correction in Spastic Cerebral Palsy NOT_YET_RECRUITING NCT07492797 Accessible Remote Rehabilitation System for Real-Time Biomechanical Monitoring NOT_YET_RECRUITING NCT07589829 The Effects of Kinesio Taping on Hallux Valgus COMPLETED NCT05883202 Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants SUSPENDED

Other Devices by Gramercy Extremity Orthopedics, LLC

K182212Geo Staple System K202817GEO Bone Screw System K200108GEO 1st MTP Joint Arthrodesis Plating System K212334GEO Extremity and Ankle 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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