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510(k) Data Aggregation
K Number
K040363Device Name
CERAMIC TIPPED SKULL PIN
Manufacturer
THE JEROME GROUP, INC.
Date Cleared
2004-04-12
(59 days)
Product Code
LYT
Regulation Number
888.3030Why did this record match?
Product Code :
LYT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Geramic Tipped Skull Pins are similar to other skull pins which, when used as part of a Halo Traction System. are designed to hold the skull firmly in place relative to the torso so cervical vertebrae are immabilized following surgery or injury.
Device Description
The Ceramic Tipped Skull Pins are similar to other skull pins which, when used as part of a Halo Traction System, are designed to hold the skull firmly in place relative to the torso so cervical vertebrae are immobilized following surgery or injury. They are the only invasive components of the Systems. The new Skull Pins include a ceramic tip. The ceramic tip reduces the possibility of an electric current passing to the patient. Such current may cause imaging artifact and/or a burning sensation at the pin insertion points.
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K Number
K983685Device Name
BONE BAND
Manufacturer
CHAPEL AND ASSOC.
Date Cleared
1998-12-04
(45 days)
Product Code
LYT
Regulation Number
888.3030Why did this record match?
Product Code :
LYT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This bone band is indicated for use in orthopedic surgery as an aid for the positioning of bone fixation plates.
This bone band is indicated for use in orthopedic surgery as an aid for reducing fractures and for the positioning of bone fixation plates.
Device Description
The bone band device consists of a 0.20" wide by 0.05" thick by 17.0" long strip of biocompatable nylon with a 0.1" wide x 0.5" long slot at each end. The surface of the band is smooth with radiused edges.
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K Number
K980594Device Name
OSTEONICS FX-CABLELOK GRIP COMPONENTS
Manufacturer
OSTEONICS CORP.
Date Cleared
1998-05-05
(77 days)
Product Code
LYT
Regulation Number
888.3030Why did this record match?
Product Code :
LYT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Osteonics® FX-Cablelok™ Grip Components are indicated for trochanteric reattachment and are intended for use with the commercially available Osteonics® FX-Cablelok™ System cable and sleeve components to provide fixation of the greater trochanter secondary to osteotomy in total hip replacement arthroplasty, surface replacement arthroplasty or any hip procedure requiring a trochanteric osteotomy.
Device Description
The subject devices are characterized by the following design features: Staple like grip design with proximal and distal hooks used in conjunction with trochanteric cable and crimp sleeves.
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