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510(k) Data Aggregation
K Number
K063157Device Name
MERRIES K-PHATE BONE GRAFT SUBSTITUTE
Manufacturer
Date Cleared
2008-03-10
(510 days)
Product Code
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
MERRIES INTERNATIONAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Merries K-PHATE is intended to be packed into bony defects of the skeletal system ( extremities, spine, or pelvis) which are not intrinsic to the stability of the bony structure. These defects may be surgically created voids or from traumatic injury to the bone. The device gradually resorbs and is replaced with bone during the healing process. Rigid fixation techniques should be used in conjunction with this device.
Device Description
Merries K-PHATE bone graft substitute is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% hydroxyapatite and 40% ß-tricalcium phosphate. Merries K-PHATE is supplied sterile in various shapes and sizes. The choice of different form or size of the product depends on the type and size of the recipient site. Blocks and wedges are used for large bony defect while granules are used as bone filler for small area.
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K Number
K051698Device Name
MERRIES UNI-OSTEO, MODEL CS30250-CS10102
Manufacturer
Date Cleared
2005-09-29
(97 days)
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
MERRIES INTERNATIONAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Merries UNI-OSTEO pellets are used to fill bony defects which may be surgically created voids or from traumatic injury to the bone. The product is indicated to be packed into bony defects of the skeletal system which is not intrinsic to the stability of the bony structure.
Device Description
Merries UNI-OSTEO pellets are made of calcium sulfate (CaSO4). These pellets dissolve safely and completely in the body in approximately 30-60 days and resorption rate corresponds with new bone growth. The product is visible on radiographs so that the implant location can be easily identified and monitored. Merries UNI-OSTEO pellets are osteoconductive meaning that these pellets act as a scaffold and facilitate new bone growth.
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