FDA 510(k)

Montross Extremity Medical Hemi Implant System

K-Nummer: K221220 · 2023-04-19

Entscheidungsdatum2023-04-19

ProduktcodeKWD

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

Montross Extremity Medical Hemi Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Montross Extremity Medical. It received FDA 510(k) clearance on 2023-04-19 under 510(k) number K221220. The device is classified under product code KWD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Montross Extremity Medical Hemi Implant System?

Montross Extremity Medical Hemi Implant System is a medical device that received FDA 510(k) clearance on 2023-04-19. The listed applicant is Montross Extremity Medical. The 510(k) number is K221220.

When did Montross Extremity Medical Hemi Implant System receive FDA 510(k) clearance?

Montross Extremity Medical Hemi Implant System received FDA 510(k) clearance on 2023-04-19, under 510(k) number K221220.

Who is the listed applicant for Montross Extremity Medical Hemi Implant System?

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

What is the FDA product code for Montross Extremity Medical Hemi Implant System?

The FDA product code for Montross Extremity Medical Hemi Implant System is KWD.

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Verwandte Geräte (Code: KWD)

K250074HYALEX® MTP Hemiarthroplasty ImplantHyalex Orthopaedics, Inc.K240268Accu-Joint Hemi ImplantAccufix Surgical, Inc.K222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLC K201393restor3d MTP ImplantRestor3D, Inc.K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC K200951Accu-Joint Hemi ImplantAccufix Surgical, Inc.

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