FortiCore®
- Primary DI
- 00814216022608
- Brand
- FortiCore®
- Company
- NANOVIS SPINE, LLC
- Model
- 11302-3412N
- Catalog number
- 11302-3412N
- Device description
- FortiCore® TLIF Spacer 12x13x34, 6 degree
- Published
- 2019-04-23
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00814216022608 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00814216022608 | 00814216022608 | 814216022608 | 0814216022608 |
GMDN Terms
| Term | Definition |
|---|
| Metal-polymer composite spinal interbody fusion cage | A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of a non-bioabsorbable synthetic polymer with a metallic coating that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device. |
Device Sizes
| Type | Value | Unit |
|---|
| Height | 12 | Millimeter |
| Length | 34 | Millimeter |
| Width | 13 | Millimeter |
Contacts
| Phone | Email |
|---|
| 8779076266 | nanovisquality@nanovistechnology.com |
Regulatory Flags
- DUNS number
- 079898044
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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