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510(k) Data Aggregation
K Number
K100373Device Name
TYCHE PEDICLE SCREW SYSTEM
Manufacturer
KYUNGWON MEDICAL CO., LTD.
Date Cleared
2010-06-30
(138 days)
Product Code
MNH, MNI
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
KYUNGWON MEDICAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tyche® Pedicle Screw System is a non-cervical, pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S 1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, The Tyche® Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
Device Description
The Tyche Pedicle Screw System is made up of muti-axial and standard screws, rods, locking cap, adjustable cross connectors. This system's intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. All components are made from medical grade titanium alloy (Ti-6Al-4V-ELI) by such as ASTM F136. The products are supplied clean and "NON STERILE".
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K Number
K092194Device Name
POLYBONE DENTAL
Manufacturer
KYUNGWON MEDICAL CO., LTD.
Date Cleared
2010-06-16
(330 days)
Product Code
LYC
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
KYUNGWON MEDICAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PolyBone® Dental is indicated to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. It is specifically for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oral, maxillofacial and dental intraosseous defects including: ridge augmentation; sinus lifts; craniofacial augmentation; filling of defects of endodontic origin; filing of cystic defects; filling of extraction site; filling of lesions of periodontal origin; repair of traumatic defects of the alveolar ridge; filling resection defects in bone tumors; cysts or other osseous defects; and substitute for autogenous of allergenic bone grafts. PolyBone® Dental is a bone graft substitute that resorbs and it is replaced with bone during the healing process.
Device Description
PolyBone® Dental is a synthetic resorbable calcium phosphate bone grafting material which consists of 100% beta-tricalcium phosphate. It is an osteoconductive material which provides a porous scaffold upon which bone formation can occur. The multidirectional interconnected porosity ranges from 75~85% with a 200~500 um pore size. Mechanism of PolyBone Dental's bone regeneration works by bone cells resorbing dicalciumphosphate dihydrate (DCPD, brushite), which is a conversion material of ß tricalcium phosphate.
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K Number
K082338Device Name
POLYBONE GRANULE & BLOCK
Manufacturer
KYUNGWON MEDICAL CO., LTD.
Date Cleared
2008-10-16
(63 days)
Product Code
MQV
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
KYUNGWON MEDICAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PolyBone® Granule & Block is indicated for filling bone voids or defects that are not intrinsic to the stability of the bony structure. PolyBone® Granule & Block is to be packed into bony voids or gaps of the skeletal system (such as extremities, spine and the pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PolyBone® Granule & Block is a bone graft substitute that resorbs and it replaced with bone during the healing process.
Device Description
PolyBone® Granule & Block is a synthetic resorbable calcium phosphate bone void filler consisted of 99.99% beta-tricalcium phosphate, and 0.01% polyphosphate. It is an osteoconductive material which provides a porous scaffold upon which bone formation can occur. The multidirectional interconnected porosity ranges from 75~85% with a 200~500 um pore size. Mechanism of PolyBone® Granule & Block's bone regeneration works by bone cells resorbing polyphosphate, which is a bone regenerating palpation material. Indication for use of PolyBone® Granule & Block is a filler of bone void regions. The device is available in a variety of shape and sizes.
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K Number
K070012Device Name
POLYBONE
Manufacturer
KYUNGWON MEDICAL CO., LTD.
Date Cleared
2007-12-27
(358 days)
Product Code
GXP
Regulation Number
882.5300Why did this record match?
Applicant Name (Manufacturer) :
KYUNGWON MEDICAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PolyBone is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defiect as well as in the augmentation or restoration of bony contour in the craniofacial skeleton.
Device Description
PolyBone consists of beta-tricalcium phosphate, monocalcium monobasic, calcium sulfate hemihydrate and polyphosphate. PolyBone is indicated for use as cranioplasty cement.
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