21 CFR 882.5960 — Tong, Skull For Traction

Neurology (NE) · Part 882 Subpart F—Neurological Therapeutic Devices · § 882.5960

Identification

Skull tongs for traction is an instrument used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation). The device is caliper shaped with tips that penetrate the skin. It is anchored to the skull and has a heavy weight attached to it that maintains, by traction, the patient's position.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
HAXTong, Skull For Traction2203rd Party
Innolitics

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