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510(k) Data Aggregation
K Number
K082617Device Name
TRAUSON GENERAL SPINAL SYSTEM (GSS)
Manufacturer
TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD.
Date Cleared
2009-01-15
(128 days)
Product Code
MNI, KWQ, MNH
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Transon General Spinal System (GSS) is intended for posterior pedicle screw fixation (GSS-VII can be applied for anterior or anterolateral fixation) of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities.
When used as a posterior spine thoracic/lumbar system, Trauson General Spinal System (GSS) is indicated for one or more of the following: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion (5) pscudarthrosis, (6) spinal stenosis.
Trauson General Spinal System (GSS) is not intended for pedicle screw fixation above T8.
Device Description
The applicant device of Trauson General Spinal System (GSS) made of Titaniuim Alloy (Ti-6AL-4V) that meet ASTM 136 is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients.
The applicant devices are not provided sterile. The materials are wildly used in the industry with well know biocompatibility. No new materials are used in the development of this implant. No surface modified or coated.
All variants use the same material, same design principle and are constant thickness.
No chemical for the enhancement of its clinical performance is applied on or incorporated into applicant device.
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K Number
K081230Device Name
TRAUSON INTRAMEDULLARY NAIL
Manufacturer
TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD.
Date Cleared
2009-01-13
(258 days)
Product Code
HSB
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Trauson Intramedullary Nail is intended to be implanted into the intramedullary canal of femur or humerus for alignment, stabilization, fixation of fractures caused by trauma or disease.
Device Description
The Trauson Intramedullary Nail made of medic 11 grade 3 16L stainless steel that meet ASTM F138 - 08 Standard Specification for Wrought 18Chromium-14 Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants. It is intended to be implanted into the intramedullary canal of femur or humerus for alignment, stabilization, fixation of fractures caused by trauma or disease. The subject devices are not provided sterile. No new materials are used in the development of this device.
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K Number
K073432Device Name
TRAUSON BONE PLATE
Manufacturer
TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD.
Date Cleared
2008-08-13
(251 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Trauson Bone Plate is intended for the fixation of fractures of humerus.
Device Description
The applicant device of Trauson Bone Plate made of medic 11 grade 3 16L stainless steel that meet ASTM F138 is intended for the fixation of fractures of humerus. The plates vary essentially through different lengths, number of plate holes. The applicant devices are not sterile. The materials are wildly used in the industry with well know biocompatibility. No new materials are used in the development of this implant. No surface modified or coated.
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K Number
K073159Device Name
TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5
Manufacturer
TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD.
Date Cleared
2008-07-23
(258 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Trauson Bone Screw is indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.
Device Description
The applicant device of Trauson Bone Screw consists of screws made of medic 11 grade 3 16L stainless steel that meet ASTM 138 is intended for fixation of fractures, fusions, or osteotomies of bones of the hand and foot. The screws are Type HA with spherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head. The applicant devices are not sterile. No new materials are used in the development of this implant.
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