K2M VENADO HA/TCP Cancellous Granules
Basic Information
- Brand Name
- K2M VENADO HA/TCP Cancellous Granules
- Primary DI
- 00816125021628
- Version / Model
- 4815-T6060
- Catalog Number
- 4815-T6060
- Company Name
- BERKELEY ADVANCED BIOMATERIALS, LLC
- Labeler DUNS
- 081067703
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-04-08
- Public Version
- 6
- Public Version Date
- 2020-06-19
- Public Version Status
- Update
- Public Device Record Key
- 3cc021cb-2be6-4b52-98df-fc31fdf2deee
Device Description
VENADO Granules Bone Graft System is a sterile bone graft comprised of Bi-Ostetic (60% hydroxyapatite and 40% beta-tri-calcium phosphate) granules. These materials have been the topic of extensive clinical studies for a several decades. VENADO Granules are safe and have excellent biocompatibility. After it is implanted, the implant resorbs and is later replaced by natural bone. VENADO Granules are a natural choice for sparing patients the trauma of autograft harvesting. It also provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission. VENADO Granules are an osteoconductive bone substitute shaped as granules that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The granules may be pressed into the void or into the surgical site by hand. The VENADO Granules provide void filling material that acts as a temporary support medium. The granules are not intended to provide structural support during the healing process. The implant is radio-opaque. VENADO Granules are biocompatible and resorbs in the body as bone ingrowth occurs.
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
- Yes
- 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 |
|---|---|---|---|---|
| 17751 | Bone matrix implant, synthetic, non-antimicrobial | 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816125021628 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K023703 | 000 |