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FDA 510(k)

Ankle Fusion Plating System

K-Number: K173121 · 2017-11-28

ApplicantIn2bones Sas
Decision Date2017-11-28
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Ankle Fusion Plating System is a medical device manufactured by In2bones Sas. It received FDA 510(k) clearance on 2017-11-28 under approval number K173121. 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 Ankle Fusion Plating System?

Ankle Fusion Plating System is a medical device that received FDA 510(k) clearance on 2017-11-28. It is manufactured by In2bones Sas. The 510(k) number is K173121.

When was Ankle Fusion Plating System approved by the FDA?

Ankle Fusion Plating System received FDA 510(k) clearance on 2017-11-28, under approval number K173121.

What company makes Ankle Fusion Plating System?

Ankle Fusion Plating System is manufactured by In2bones Sas.

What is the FDA product code for Ankle Fusion Plating System?

The FDA product code for Ankle Fusion 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 NCT07589829 The Effects of Kinesio Taping on Hallux Valgus COMPLETED NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07556198 Effects of Whole-Body Vibration With Foot Core Exercises: A Randomized Controlled Trial COMPLETED NCT03965143 Talus Replacement Registry RECRUITING NCT04305925 Focal Laser Ablation of Prostate Cancer COMPLETED

Other Devices by In2bones Sas

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Related Devices (Code: HRS)

K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc. K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate AG

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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