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510(k) Data Aggregation
K Number
K151362Device Name
HC Spinal System
Manufacturer
HUNG CHUN BIO-S CO., LTD.
Date Cleared
2016-05-05
(350 days)
Product Code
MNH, MNI
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
HUNG CHUN BIO-S CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HC Spinal System is intended for posterior noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients for the following indications: severe spondylolisthesis (i.e., Grades 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment), trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.
Device Description
The HC Spinal System offers a comprehensive solution for immobilizing and stabilizing spinal deformities in patients as an adjunct to fusion. The HC Spinal System consists of monoaxial and polyaxial pedicle screws, set screw and rods. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy. The implants will be provided non-sterile and will be used for either posterior or anterolateral non cervical fixation.
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K Number
K110425Device Name
HC-BIOS DENTAL IMPLANT
Manufacturer
HUNG CHUN BIO-S CO., LTD.
Date Cleared
2012-07-27
(529 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
HUNG CHUN BIO-S CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HC-Bios Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.
This may be accomplished by either a two-stage surgical procedure or a single surgical procedure. If a single surgical procedure is used, single or multiple implants may be inserted (type I, II or III bone) provided good initial stability (> 40 Ncm) is achieved. Not intended for immediate loading.
Device Description
The HC-Bios Dental Implant System is a device made of pure titanium metal and titanium alloy intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. It consists of fixture, abutment, mount screw, cover screw, impression coping, analog, impression coping screw and plastic impression cap. Its materials, dimensions, and intended use are similar to devices currently marketed worldwide.
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