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510(k) Data Aggregation
K Number
K143013Device Name
Spinal Inner Fixation System
Manufacturer
Changzhou Dingjian Medical Appliance Co., Ltd
Date Cleared
2015-12-11
(417 days)
Product Code
MNH, KWP, MNI
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
Changzhou Dingjian Medical Appliance Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Spinal inner fixation system is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization and immobilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.
Device Description
Spinal inner fixation system consists of a variety of shapes and sizes of pedicle screws, rods, hooks, transverse linking pole assembly, and connecting components (side, domino, and axial), which can be rigidly locked into a variety of configurations. These components are made of titanium alloy per ASTM F136.
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K Number
K143002Device Name
Metallic Locking Bone Plate and Screw System
Manufacturer
Changzhou Dingjian Medical Appliance Co., Ltd
Date Cleared
2015-06-05
(228 days)
Product Code
HRS, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Changzhou Dingjian Medical Appliance Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Metallic Locking Bone Plate and Screw System are intents with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur and tibia.
Device Description
The proposed device, Metallic Locking Bone Plate and Screw System consists of bone plate and screw. The bone plates are used for internal fixation of bone fracture, including ulna, radius, humerus, femur and tibia. Implant is made of Ti6Al4V Eli and titanium which conforms to ASTM F 136 and ASTM F67.
The proposed devices are provided un-sterilized. They shall be sterilized prior to use by healthcare provider. The proposed devices shall never be reused.
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