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FDA 510(k)

SOLE Medial Column Fusion Plate

K-Number: K210157 · 2021-04-20

ApplicantOrthofix Srl
Decision Date2021-04-20
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SOLE Medial Column Fusion Plate is a medical device manufactured by Orthofix Srl. It received FDA 510(k) clearance on 2021-04-20 under approval number K210157. 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 SOLE Medial Column Fusion Plate?

SOLE Medial Column Fusion Plate is a medical device that received FDA 510(k) clearance on 2021-04-20. It is manufactured by Orthofix Srl. The 510(k) number is K210157.

When was SOLE Medial Column Fusion Plate approved by the FDA?

SOLE Medial Column Fusion Plate received FDA 510(k) clearance on 2021-04-20, under approval number K210157.

What company makes SOLE Medial Column Fusion Plate?

SOLE Medial Column Fusion Plate is manufactured by Orthofix Srl.

What is the FDA product code for SOLE Medial Column Fusion Plate?

The FDA product code for SOLE Medial Column Fusion Plate is HRS.

Related Clinical Trials

NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

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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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