Golden Isles Pedicle Screw System
- Primary DI
- G079C5110000010
- Brand
- Golden Isles Pedicle Screw System
- Company
- Intelivation, LLC
- Model
- C51-1000-001
- Device description
- Standard Headbody Assembly
- Published
- 2022-09-23
- 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 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| G079C5110000010 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Bone-screw internal spinal fixation system, non-sterile | An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 037368183
- 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 |
|---|
| G079HMR2020 | Hammerdesis™ Interphalangeal Fusion System | HMR-202 | | 2026-03-05 |
| G079HMR3020 | Hammerdesis™ Interphalangeal Fusion System | HMR-302 | | 2026-03-05 |
| G079HMR4020 | Hammerdesis™ Interphalangeal Fusion System | HMR-402 | | 2026-03-05 |
| G079C2520003900 | Golden Isles Pedicle Screw System | C25-2000-390 | | 2026-03-04 |
| G079C2520004000 | Golden Isles Pedicle Screw System | C25-2000-400 | | 2026-03-04 |
| G079C2520004100 | Golden Isles Pedicle Screw System | C25-2000-410 | | 2026-03-04 |
| G079C2520004200 | Golden Isles Pedicle Screw System | C25-2000-420 | | 2026-03-04 |
| G079C2520004300 | Golden Isles Pedicle Screw System | C25-2000-430 | | 2026-03-04 |
| G079C2520004400 | Golden Isles Pedicle Screw System | C25-2000-440 | | 2026-03-04 |
| G079C2520004500 | Golden Isles Pedicle Screw System | C25-2000-450 | | 2026-03-04 |
| G079C2520004600 | Golden Isles Pedicle Screw System | C25-2000-460 | | 2026-03-04 |
| G079C2520004700 | Golden Isles Pedicle Screw System | C25-2000-470 | | 2026-03-04 |
| G079C2520004800 | Golden Isles Pedicle Screw System | C25-2000-480 | | 2026-03-04 |
| G079C2520004900 | Golden Isles Pedicle Screw System | C25-2000-490 | | 2026-03-04 |
| G079C2520005000 | Golden Isles Pedicle Screw System | C25-2000-500 | | 2026-03-04 |
| G079C2520002600 | Golden Isles Pedicle Screw System | C25-2000-260 | | 2026-03-03 |
| G079C2520002700 | Golden Isles Pedicle Screw System | C25-2000-270 | | 2026-03-03 |
| G079C2520002800 | Golden Isles Pedicle Screw System | C25-2000-280 | | 2026-03-03 |
| G079C2520002900 | Golden Isles Pedicle Screw System | C25-2000-290 | | 2026-03-03 |
| G079C2520003000 | Golden Isles Pedicle Screw System | C25-2000-300 | | 2026-03-03 |
Other Devices Sharing Product Codes
intelivationtech.com