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510(k) Data Aggregation
K Number
K171863Device Name
Anjon Bremer Halo System
Manufacturer
Anjon Holdings, LLC
Date Cleared
2018-03-19
(270 days)
Product Code
JEC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Anjon Holdings, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Anjon Bremer Halo System is indicated for use to provide cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck condition.
Device Description
The Anjon Bremer Halo System consists of transcutaneous bone anchorage elements, and extracutaneous bridge elements, which provide fixation of the torso to immobilize the cervical spine when used with a frame or surgical table adaptor. The transcutaneous bone anchorage elements are titanium threaded skull pins, of which four (4) skull pins attach to an aluminum crown or ring positioned below the head equator. The crown or ring is then attached to an aluminum rod superstructure, which is attached to a lined polymer vest, or attached to a surgical table using the Mayfield adaptor. All materials are MRI/CT conditional.
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