A8 INTEGR8® Porous Pedicle Screw System
- Primary DI
- 00850062071957
- Brand
- A8 INTEGR8® Porous Pedicle Screw System
- Company
- ALLUMIN8, INC.
- Model
- RST-60-0110
- Catalog number
- RST-60-0110
- Device description
- Ti Rod - Straight 6.0x110mm
- 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
- false
- 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 |
|---|
| 00850062071957 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Bone-screw internal spinal fixation system rod | An implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine. |
Device Sizes
| Type | Value | Unit |
|---|
| Length | 110 | Millimeter |
| Outer Diameter | 6 | Millimeter |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts
| Phone | Email |
|---|
| +1 (417) 689-2424 | info@allumin8.com |
Regulatory Flags
- DUNS number
- 121774080
- Device count
- 1
- 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
- true
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 |
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