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FDA 510(k)

Stratum® Ankle Fusion Plating System

K-Number: K212640 · 2021-11-18

ApplicantNextremity Solutions, Inc.
Decision Date2021-11-18
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Stratum® Ankle Fusion Plating System is a medical device manufactured by Nextremity Solutions, Inc.. It received FDA 510(k) clearance on 2021-11-18 under approval number K212640. 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 Stratum® Ankle Fusion Plating System?

Stratum® Ankle Fusion Plating System is a medical device that received FDA 510(k) clearance on 2021-11-18. It is manufactured by Nextremity Solutions, Inc.. The 510(k) number is K212640.

When was Stratum® Ankle Fusion Plating System approved by the FDA?

Stratum® Ankle Fusion Plating System received FDA 510(k) clearance on 2021-11-18, under approval number K212640.

What company makes Stratum® Ankle Fusion Plating System?

Stratum® Ankle Fusion Plating System is manufactured by Nextremity Solutions, Inc..

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

The FDA product code for Stratum® 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 NCT07587593 The IVCare Adaptive Platform Trial NOT_YET_RECRUITING 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

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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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