Search Results
Found 1 results
510(k) Data Aggregation
K Number
K070220Device Name
OSTEOFIX BONE VOID FILLER
Manufacturer
CALCITEC, INC
Date Cleared
2007-04-12
(79 days)
Product Code
MQV
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
CALCITEC, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Osteofix™ Bone Void Filler is indicated for use to fill bony voids or gaps that are not intrinsic to the stability of the bony structure. Osteofix™ Bone Void Filler is intended to be injected into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a Bone Void Filler that resorbs and is replaced with bone during the healing process.
Device Description
Osteofix™ Bone Void Filler is a synthetic, injectable, resorbable, Bone Void Filler.
Ask a Question
Page 1 of 1