Search Results
Found 6 results
510(k) Data Aggregation
K Number
K090733Device Name
PMT HALO SYSTEM
Manufacturer
PMT CORP.
Date Cleared
2009-07-28
(131 days)
Product Code
HAX
Regulation Number
882.5960Why did this record match?
Product Code :
HAX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PMT Halo System with Open Back Carbon Graphite and Titanium Skull Pins and the PMT Halo System with Closed Back Carbon Graphite and Titanium Skull Pins provides cervical immobilization necessary for healing and rehabilitation of cervical spinal cord injuries.
The PMT Halo system is MR Conditional and may be used safely in an MRI under the following conditions:
- Static magnetic field of 1.5T and 3T only .
- Maximum spatial gradient magnetic field of 720 Gauss/cm or less .
- Normal operating mode with a maximum MR system reported, whole body averaged specific absorption rate (SAR) ● of 3.0 W/kg for 15 minutes of scanning (per pulse sequence).
Device Description
The PMT Halo System is designed for positioning and stabilization of the cervical spine area. It provides optimum external immobilization and traction for the cervical region while allowing the patient to leave the hospital and resume their normal activities.
To enhance the magnetic resonance imaging compatibility, the PMT Halo system utilizes non-magnetic titanium skull pins and hardware, brass positioning pins, and advanced non-metallic support materials such as carbon graphite upright bars and composite head fixation subassemblies.
Ask a Question
K Number
K071173Device Name
RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D
Manufacturer
OSSUR AMERICANS (FORMERLY THE JEROME GROUP)
Date Cleared
2007-05-25
(28 days)
Product Code
HAX
Regulation Number
882.5960Why did this record match?
Product Code :
HAX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ReSolve Tongs are intended for use to provide longitudinal traction to align vertebral structures, maintain reduction, or provide stabilization for a cervical spine injury.
Device Description
The ReSolve Tongs are similar to other traction tongs which are used to provide longitudinal traction to align vertebral structures, maintain reduction, or provide stabilization for a cervical spine injury.
Ask a Question
K Number
K051918Device Name
RESOLVE OPEN BACK HALO RINGS
Manufacturer
JEROME MEDICAL
Date Cleared
2005-08-17
(33 days)
Product Code
HAX
Regulation Number
882.5960Why did this record match?
Product Code :
HAX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ReSOLVE Open Back Halo Ring is intended for use with a Jerome Halo Vest to immobilize and/or provide traction for a cervical spine injury.
Device Description
The ReSOLVE Open Back Halo Traction Ring is similar to other rings which, when used as part of a Halo System, are designed to hold the skull immobilized following surgery or injury.
Ask a Question
K Number
K023959Device Name
JEROME GLASS RING
Manufacturer
THE JEROME GROUP, INC.
Date Cleared
2003-02-21
(86 days)
Product Code
HAX
Regulation Number
882.5960Why did this record match?
Product Code :
HAX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Jerome Glass Ring is intended for use with a Jerome Halo Vest to immobilize and/or provide traction for a cervical spine injury.
Device Description
The Fiberglass Halo Traction Ring is similar to other halo rings which. when used as part of a Halo System, are designed to hold the skull firmly in place relative to the torso so cervical vertebrae are immobilized following surgery or injury.
Ask a Question
K Number
K003662Device Name
SPINE WORKS COLLAR
Manufacturer
SPINE WORKS
Date Cleared
2001-07-09
(223 days)
Product Code
HAX
Regulation Number
882.5960Why did this record match?
Product Code :
HAX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
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?
Product Code :
HAX
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.
Ask a Question
Page 1 of 1