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510(k) Data Aggregation
K Number
K060809Device Name
OSTEO-LINK BONE VOID FILLER PELLETS
Manufacturer
PROMED ADVANCE TECHNOLOGY CO., LTD.
Date Cleared
2006-07-03
(101 days)
Product Code
MQV
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
PROMED ADVANCE TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Osteo-Link Bone Void Filler Pellets are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. These pellets are indicated to be gently packed into bony voids or gap of the skeletal system; such as the extremities, spine and pelvis. Theses defects may be surqically created osseous defects or osseous defects created from traumatic injury to the bone. The pellets provide the bone void filler that resorbs and is replaced with bone during the healing process.
Device Description
Osteo-Link Bone Void Filler Pellets are made of high purity pharmaceutical grade calcium sulfate. The biodegradable, radiopaque pellets are resorbed in approximately 14 weeks when used according to labeling. Osteo-Link Bone Void Filler Pellets are provide sterile for single patient use.
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