A8 INTEGR8® Porous Pedicle Screw System
- Primary DI
- 00850062071193
- Brand
- A8 INTEGR8® Porous Pedicle Screw System
- Company
- ALLUMIN8, INC.
- Model
- A8-65-0050
- Catalog number
- A8-65-0050
- Device description
- A8 INTEGR8 Cannulated Fenestrated Porous Pedicle Screw Ø6.5x50mm
- Published
- 2026-02-27
- Public version status
- New
- 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 |
|---|
| NKB | Thoracolumbosacral Pedicle Screw System |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K242827 | 000 | A8 INTEGR8 Porous Pedicle Screws | Allumin8, Inc. | 2025-10-20 | NKB |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10850062071190 | Primary | GS1 | 0 | |
| 00850062071193 | Unit of Use | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 10850062071190 | 10850062071190 | | |
| 00850062071193 | 00850062071193 | 850062071193 | 0850062071193 |
GMDN Terms
| Term | Definition |
|---|
| 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. |
Device Sizes
| Type | Value | Unit |
|---|
| Length | 50 | Millimeter |
| Outer Diameter | 6.5 | Millimeter |
Regulatory Flags
- DUNS number
- 121774080
- Device count
- 2
- 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
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 00850062071001 | A8 INTEGR8® Porous Pedicle Screw System | A8-00-CAP | A8-00-CAP | 2026-02-27 |
| 00850062071506 | A8 INTEGR8® Porous Pedicle Screw System | RST-55-0025 | RST-55-0025 | 2026-02-27 |
| 00850062071513 | A8 INTEGR8® Porous Pedicle Screw System | RST-55-0030 | RST-55-0030 | 2026-02-27 |
| 00850062071520 | A8 INTEGR8® Porous Pedicle Screw System | RST-55-0035 | RST-55-0035 | 2026-02-27 |
| 00850062071537 | A8 INTEGR8® Porous Pedicle Screw System | RST-55-0040 | RST-55-0040 | 2026-02-27 |
| 00850062071544 | A8 INTEGR8® Porous Pedicle Screw System | RST-55-0045 | RST-55-0045 | 2026-02-27 |
| 00850062071551 | A8 INTEGR8® Porous Pedicle Screw System | RST-55-0050 | RST-55-0050 | 2026-02-27 |
| 00850062071568 | A8 INTEGR8® Porous Pedicle Screw System | RST-55-0055 | RST-55-0055 | 2026-02-27 |
| 00850062071575 | A8 INTEGR8® Porous Pedicle Screw System | RST-55-0060 | RST-55-0060 | 2026-02-27 |
| 00850062071582 | A8 INTEGR8® Porous Pedicle Screw System | RST-55-0065 | RST-55-0065 | 2026-02-27 |
| 00850062071599 | A8 INTEGR8® Porous Pedicle Screw System | RST-55-0070 | RST-55-0070 | 2026-02-27 |
| 00850062071605 | A8 INTEGR8® Porous Pedicle Screw System | RST-55-0075 | RST-55-0075 | 2026-02-27 |
| 00850062071612 | A8 INTEGR8® Porous Pedicle Screw System | RST-55-0080 | RST-55-0080 | 2026-02-27 |
| 00850062071629 | A8 INTEGR8® Porous Pedicle Screw System | RST-55-0085 | RST-55-0085 | 2026-02-27 |
| 00850062071636 | A8 INTEGR8® Porous Pedicle Screw System | RST-55-0090 | RST-55-0090 | 2026-02-27 |
| 00850062071643 | A8 INTEGR8® Porous Pedicle Screw System | RST-55-0095 | RST-55-0095 | 2026-02-27 |
| 00850062071650 | A8 INTEGR8® Porous Pedicle Screw System | RST-55-0100 | RST-55-0100 | 2026-02-27 |
| 00850062071667 | A8 INTEGR8® Porous Pedicle Screw System | RST-55-0110 | RST-55-0110 | 2026-02-27 |
| 00850062071674 | A8 INTEGR8® Porous Pedicle Screw System | RST-55-0120 | RST-55-0120 | 2026-02-27 |
| 00850062071681 | A8 INTEGR8® Porous Pedicle Screw System | RST-55-0130 | RST-55-0130 | 2026-02-27 |
Other Devices Sharing Product Codes
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