FDA UDI
In Commercial Distribution
🇺🇸 United States
A8 INTEGR8® Porous Pedicle Screw System
DI: 10850062071473
·
Model: A8-85-0050
·
ALLUMIN8, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
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Basic Information
- Brand Name
- A8 INTEGR8® Porous Pedicle Screw System
- Primary DI
- 10850062071473
- Version / Model
- A8-85-0050
- Catalog Number
- A8-85-0050
- Company Name
- ALLUMIN8, INC.
- Labeler DUNS
- 121774080
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2026-02-27
- Public Version
- 1
- Public Version Date
- 2026-03-09
- Public Version Status
- New
- Public Device Record Key
- 1e8bbf2b-725b-45c4-9dbf-5568b01a4759
Device Description
A8 INTEGR8 Cannulated Fenestrated Porous Pedicle Screw Ø8.5x50mm
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | 888.3070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46651 | Spinal bone screw, non-bioabsorbable | A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00850062071476 | GS1 | ||||
| Primary | 10850062071473 | GS1 |
Customer Contacts
- Phone
- 1-417-689-2424
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K242827 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 8.5 | Millimeter | |
| Length | 50 | Millimeter |