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Tong, Skull For Traction

Page Type
Product Code
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5960
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 882.5960 Skull tongs for traction

§ 882.5960 Skull tongs for traction.

(a) 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.

(b) Classification. Class II (performance standards).

Tong, Skull For Traction

Page Type
Product Code
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5960
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 882.5960 Skull tongs for traction

§ 882.5960 Skull tongs for traction.

(a) 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.

(b) Classification. Class II (performance standards).