FDA UDI
In Commercial Distribution
🇺🇸 United States
A8 INTEGR8® Porous Pedicle Screw System
DI: 00850062071759
·
Model: RST-55-0200
·
ALLUMIN8, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- A8 INTEGR8® Porous Pedicle Screw System
- Primary DI
- 00850062071759
- Version / Model
- RST-55-0200
- Catalog Number
- RST-55-0200
- Company Name
- ALLUMIN8, INC.
- Labeler DUNS
- 121774080
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- 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
- a9a1ff8c-f4d0-4f9c-b6d2-db1b8bcd0b8d
Device Description
Ti Rod - Straight 5.5x200mm
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
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
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 |
|---|---|---|---|---|
| 65116 | 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850062071759 | 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 | 5.5 | Millimeter | |
| Length | 200 | Millimeter |