IN-DATE
ATM0110: Formosa Biomedical A-Grix TE Resorbable Bone Void Filler 10cc
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| Price: | $199.00 per box of 1 |
|---|---|
| Quantity: | |
| In Stock: | 2 box of 1 |
| Status: | expired |
The item listed above is expired and may be used for educational, training, and non-clinical research purposes only. Any product information appearing below, including the product indication statement, pertains to an in date item only.
Additional Details
Formosa Biomedical ATM0110 A-GRIX TE Resorbable Bone Void Filler 10 cc
Formosa Biomedical ATM0110 A-GRIX TE Resorbable Bone Void Filler is a 10 cc resorbable orthopedic bone void filler designed to fill bony voids or gaps in the skeletal system that are not intrinsic to structural stability. The calcium salt material is mixed before use to form a biodegradable, biocompatible, radiopaque paste or putty that hardens in situ and provides an osteoconductive scaffold while the material is gradually resorbed and replaced by new bone during healing. A-GRIX TE is indicated for defects in the extremities and pelvis, including surgically created osseous defects and defects resulting from traumatic injury.
Product Code: ATM0110
- Manufacturer: Formosa Biomedical Technology Corporation
- Product name: A-GRIX TE Resorbable Bone Void Filler
- Product family: A-GRIX TE
- Product type: Resorbable bone void filler
- Volume: 10 cc
- Material: Surgical-grade calcium salt mixture
- Final consistency after mixing: Paste or putty
- Properties: Biodegradable, biocompatible, radiopaque, osteoconductive
- Clinical application: Filling bony voids and gaps that are not intrinsic to the stability of the bone structure
- Anatomical applications: Extremities and pelvis
- Procedure types: Orthopedic bone defect filling, treatment of surgically created osseous defects, and treatment of traumatic bone defects
- Specialty: Orthopedic Surgery
- Implantable: Yes
Contents
- Pre-measured surgical-grade calcium salt mixture
- Mixing solution
Features
- Hardens in situ after mixing and placement
- Provides temporary intraoperative support within the bone defect
- Functions as an osteoconductive scaffold to support new bone growth
- Resorbs during the healing process and is replaced by new bone
- Radiopaque formulation supports visualization after placement
- May be used at an infected site when clinically appropriate
Sterilization
- Device Packaged as Sterile: Yes
- Requires Sterilization Prior to Use: No
- Single-Use, Disposable
AccessGUDID Info
- FDA Product Code: MQV
- FDA Product Code Name: FILLER, BONE VOID, CALCIUM COMPOUND
- GMDN Term Code: 17751
- GMDN Term Name: Bone matrix implant, synthetic, non-antimicrobial
- GMDN Term Description: A bioabsorbable device made of synthetic material intended to be implanted into the body to provide osteoconductive bone-tissue scaffolds, and sometimes osteovascularization, to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis); it does not include an antimicrobial agent(s). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts and is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable/fluid materials.
