FDA UDI
In Commercial Distribution
🇺🇸 United States
SUPSTANCE Large
DI: 03700449614765
·
Model: 100128400
·
H.P.I.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SUPSTANCE Large
- Primary DI
- 03700449614765
- Version / Model
- 100128400
- Catalog Number
- 100128400
- Company Name
- H.P.I.
- Labeler DUNS
- 268469389
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-11-12
- Public Version
- 3
- Public Version Date
- 2020-02-24
- Public Version Status
- Update
- Public Device Record Key
- 0f9a1053-448e-46ab-b44b-d0e6ce1c454a
Device Description
The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended to replace a vertebral body. It is designed for use in the thoracolumbar spine (T1 - L5) to replace a collapsed, damaged or unstable vertebral body during tumor or trauma (i.e, fracture) management procédures.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | 888.3060 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60762 | Polymeric 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 non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03700449614765 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Angle | 5 | degree | |
| Length | 40 | Millimeter | |
| Outer Diameter | 28 | Millimeter |