FDA UDI
In Commercial Distribution
🇺🇸 United States
SIGNAFUSE Bioactive Bone Graft
DI: 00816986020488
·
Model: 25X25X8 MM, 5 CC
·
BIOVENTUS LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SIGNAFUSE Bioactive Bone Graft
- Primary DI
- 00816986020488
- Version / Model
- 25X25X8 MM, 5 CC
- Catalog Number
- SGFS-005
- Company Name
- BIOVENTUS LLC
- Labeler DUNS
- 078450878
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-30
- Public Version
- 1
- Public Version Date
- 2020-08-07
- Public Version Status
- New
- Public Device Record Key
- 5c2c3c3f-6f2a-4559-a25a-d7c8c9f19ad1
Device Description
SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.
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
- No
- 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 |
|---|---|---|---|---|
| 16966 | Synthetic bone graft | An artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816986020488 | GS1 |
Customer Contacts
- Phone
- 800-637-4391
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K193513 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius