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510(k) Data Aggregation
K Number
K980689Device Name
FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM
Manufacturer
FRIDDLE'S ORTHOPEDIC APPLIANCES, INC.
Date Cleared
1999-02-18
(360 days)
Product Code
HAX
Regulation Number
882.5960Why did this record match?
Applicant Name (Manufacturer) :
FRIDDLE'S ORTHOPEDIC APPLIANCES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is designed to provide traction and/or to immobilize a patient with a cervical spine injury or after surgery.
Device Description
The Friddle Halo system is very similar to several halo systems, which are designed to hold the skull firmly in place relative to the torso so that the cervical vertabrae are immobolized after surgery or injury. The system is comprised of a ring, rods, and braces system made of a carbon fiber-epoxy composite which is placed over a vest made of high-density polyethylene, lined with Kodel or sometimes sheepskin. The skull pins are made of CP titanium. The titanium skull pins, carbon fiber-epoxy composite rods, high-density polyethylene, Kodel, and sheepskin are used throughout the industry.
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