21 CFR 888.3020 — Rod, Fixation, Intramedullary And Accessories

Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3020

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.

Product Codes

Product CodeDevice NameClassDevicesAttributes
HSBRod, Fixation, Intramedullary And Accessories2522Implant
NDERod, Fixation, Intramedullary And Accessories, Metallic And Non-Collapsible20Implant
SAIAnkle Fusion Cage22Implant
Innolitics

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