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FDA 510(k)

ExtremiLOCK Lateral Ankle Fusion Plates

K-Number: K203479 · 2021-02-24

ApplicantOsteomed
Decision Date2021-02-24
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ExtremiLOCK Lateral Ankle Fusion Plates is the device name listed in this FDA 510(k) record. The listed applicant is Osteomed. It received FDA 510(k) clearance on 2021-02-24 under 510(k) number K203479. 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 ExtremiLOCK Lateral Ankle Fusion Plates?

ExtremiLOCK Lateral Ankle Fusion Plates is a medical device that received FDA 510(k) clearance on 2021-02-24. The listed applicant is Osteomed. The 510(k) number is K203479.

When did ExtremiLOCK Lateral Ankle Fusion Plates receive FDA 510(k) clearance?

ExtremiLOCK Lateral Ankle Fusion Plates received FDA 510(k) clearance on 2021-02-24, under 510(k) number K203479.

Who is the listed applicant for ExtremiLOCK Lateral Ankle Fusion Plates?

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

What is the FDA product code for ExtremiLOCK Lateral Ankle Fusion Plates?

The FDA product code for ExtremiLOCK Lateral Ankle Fusion Plates is HRS.

Other records listing Osteomed as applicant

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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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