Orthopedic

NDE · Rod, Fixation, Intramedullary And Accessories, Metallic And Non-Collapsible

Orthopedic · 21 CFR 888.3020 · Class 2

Overview

Product CodeNDE
Device NameRod, Fixation, Intramedullary And Accessories, Metallic And Non-Collapsible
Regulation21 CFR 888.3020
Device ClassClass 2
Review PanelOrthopedic
ImplantYes

Identification

An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Classification Rationale

Class II.

Cleared Devices (0)

No cleared devices on record.

Innolitics

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