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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 the device name listed in this FDA 510(k) record. The listed applicant is Orthofix Srl. It received FDA 510(k) clearance on 2021-04-20 under 510(k) 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. The listed applicant is Orthofix Srl. The 510(k) number is K210157.

When did SOLE Medial Column Fusion Plate receive FDA 510(k) clearance?

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

Who is the listed applicant for SOLE Medial Column Fusion Plate?

The FDA 510(k) record lists Orthofix Srl as the applicant. This does not by itself establish the device manufacturer.

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

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

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Related Devices (Code: HRS)

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.

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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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