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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 the device name listed in this FDA 510(k) record. The listed applicant is Nextremity Solutions, Inc.. It received FDA 510(k) clearance on 2021-11-18 under 510(k) 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. The listed applicant is Nextremity Solutions, Inc.. The 510(k) number is K212640.

When did Stratum® Ankle Fusion Plating System receive FDA 510(k) clearance?

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

Who is the listed applicant for Stratum® Ankle Fusion Plating System?

The FDA 510(k) record lists Nextremity Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for Stratum® Ankle Fusion Plating System 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.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

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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