Collage Osteoconductive Scaffold - Putty
Basic Information
- Brand Name
- Collage Osteoconductive Scaffold - Putty
- Primary DI
- 10381780112044
- Version / Model
- 710005
- Catalog Number
- 710005
- Company Name
- Integra Lifesciences Corporation
- Labeler DUNS
- 083171244
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-16
- Public Version
- 6
- Public Version Date
- 2023-08-15
- Public Version Status
- Update
- Public Device Record Key
- f3668154-6cd8-465e-a3d1-62b248a14900
- Distribution End Date
- 2023-07-31
Device Description
The Orthofix Collage Osteoconductive Scaffold - Putty (Orthofix Collage Putty) is a resorbable bone void filler made from a porous highly purified collagen matrix that has high purity tricalcium phosphate (TCP) granules dispersed throughout. The implant is provided sterile, nonpyrogenic, for single use in double peel packages. The Orthofix Collage Putty bone grafting construct is designed to facilitate the repair of bony defects. In the dry state, the matrix has a three dimensional trabecular network of pores that resembles the pore structure of human cancellous bone. The Orthofix Collage Putty quickly imbibes fluids, making it easy to combine with bone marrow aspirate. The Orthofix Collage Putty guides the regeneration of bone across the defect site into which the Putty is implanted. New bone forms in apposition to the matrix surface when the graft is placed in direct contact with viable host bone. Ultimately the matrix is resorbed and remodeled into bone.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MQV | FILLER, BONE VOID, CALCIUM COMPOUND | Orthopedic | 888.3045 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47967 | Bone matrix implant, composite | A sterile bioabsorbable device made of synthetic bone substitute materials (e.g., ceramics such as tricalcium phosphate or hydroxyapatite) combined with bone growth factors (e.g., bovine collagen) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts. It is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable materials. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10381780112044 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 5 cc |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 25 Degrees Celsius