ETEX AccuFill Injectable Calcium Phosphate

Singapore - English - HSA (Health Sciences Authority)

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Available from:
ZIMMER PTE. LTD.
Class:
Class D medical device
Manufactured by:
ETEX Corporation
Therapeutic area:
Orthopaedics
Therapeutic indications:
Accufill Injectable Calcium Phosphate is an injectable, self setting, macro-porous, osteo-conductive, calcium phosphate bone graft substitute material that is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e. posterolateral spine), and the pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Accufill Injectable Calcium Phosphate is a bone graft substitute that resorbs and is replaced with new bone during the healing process.
Product summary:
Device System Info:[Sterile Medical Device], Gamma radiation; Models: AccuFill 3cc Injectable Calcium Phosphate - 201.030, AccuFill 5cc Injectable Calcium Phosphate - 201.050
Authorization number:
DE0501905
Authorization date:
2018-07-17

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