FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Fortilink®-L IBF System with TETRAfuse 3D Technology
DI: 00846468087166
·
Model: 65-L-1450-8
·
Pioneer Surgical Technology, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Fortilink®-L IBF System with TETRAfuse 3D Technology
- Primary DI
- 00846468087166
- Version / Model
- 65-L-1450-8
- Catalog Number
- 65-L-1450-8
- Company Name
- Pioneer Surgical Technology, Inc.
- Labeler DUNS
- 793384496
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-24
- Public Version
- 5
- Public Version Date
- 2026-02-20
- Public Version Status
- Update
- Public Device Record Key
- afdb7d79-0d69-4933-a4de-b634347bf2df
- Distribution End Date
- 2023-07-21
Device Description
Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 14mm (W), 50mm (L), 8mm (H)
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 |
|---|---|---|---|---|
| MAX | Intervertebral fusion device with bone graft, lumbar | Orthopedic | 888.3080 | 2 |
| ODP | Intervertebral fusion device with bone graft, cervical | 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 | 00846468087166 | GS1 |
Customer Contacts
- Phone
- +1(906)226-9909
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 14mm (W), 50mm (L), 8mm (H) |