Nazione: Singapore
Lingua: inglese
Fonte: HSA (Health Sciences Authority)
NUVASIVE SOUTHEAST ASIA PTE. LTD.
Class D medical device
Nuvasive Inc
Orthopaedics
Formagraft is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed 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 bone void filler that resorbs and is replaced by the growth of new bone during the healing process. The bone graft can be mixed with autogenous bone marrow prior to use at the physician’s discretion. In weight bearing situations, Formagraft is to be used in conjunction with internal or external fixation devices. The fracture defect treated with Formagraft should not exceed 30 mL.
Device System Info:[Sterile Medical Device], Radiation sterilisation; Models: 6-Port Nv Bma Needle, 4in - 5010004, 6-Port Nv Bma Needle, 6in - 5010006, 6-Port Bone Marrow Aspiration Needle (4in.) - 5010001, 6-Port Aspiration Needle, 8in - 5010008, Formagraft® Granules, 5cc - 5010005, Formagraft® Granules, 10cc - 5010010, Formagraft® Granules, 20cc - 5010020, Formagraft® Xl Block, Small - 5010085, Formagraft® Xl Block, Large - 5010125, Formagraft® Sterile Strips (2) - 5010200, Formagraft® Sterile Strips Small (2) - 5010205
2011-05-12