FDA UDI
In Commercial Distribution
🇺🇸 United States
InterFuse L
DI: 00819475010625
·
Model: 9119-08-21-45-0
·
VERTEBRAL TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- InterFuse L
- Primary DI
- 00819475010625
- Version / Model
- 9119-08-21-45-0
- Catalog Number
- 9119-08-21-45-0
- Company Name
- VERTEBRAL TECHNOLOGIES, INC.
- Labeler DUNS
- 362264421
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-15
- Public Version
- 4
- Public Version Date
- 2020-02-24
- Public Version Status
- Update
- Public Device Record Key
- d7529d5b-609f-4342-9d95-9e8c526d6989
Device Description
Intervertebral Body Fusion Device
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
- MR Safe
- 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 |
|---|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | 888.3080 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34170 | Vertebral body prosthesis | An implantable device designed to replace one or more vertebral body(s) that has collapsed or been surgically removed due to trauma, tumour or degenerative disease. Also known as a corpectomy or vertebrectomy spacer, it is in the form of a one-piece or modular hollow cylinder made of inorganic materials (e.g., metal, polymer). It is typically used with supplemental spinal fixation and/or bone graft, and some types are adjustable for in situ adjustment of prosthesis height to allow intraoperative distraction of adjacent vertebrae. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00819475010625 | GS1 |
Customer Contacts
- Phone
- 952-912-5400
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131540 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 8 | Millimeter | |
| Width | 21 | Millimeter | |
| Angle | 0 | degree | |
| Length | 45 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Ambient temperatures in a clean dry area