Golden Isles Pedicle Screw System
- Primary DI
- G079C5040000010
- Brand
- Golden Isles Pedicle Screw System
- Company
- Intelivation, LLC
- Model
- C50-4000-001
- Device description
- French Rod Bender
- 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
- false
Product Codes
| Code | Name |
|---|
| HXP | Instrument, Bending Or Contouring |
| NKB | Thoracolumbosacral Pedicle Screw System |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| HXP | Instrument, Bending Or Contouring | Orthopedic | 1 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| G079C5040000010 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Manual orthopaedic bender, reusable | A manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. The bending process is typically performed within the operating room (OR), inside or outside of the operative sterile field. The device may be hand held or table mounted. This is a reusable device. |
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