FDA UDI
In Commercial Distribution
🇺🇸 United States
CarboClear Hybrid Pedicle Screw System
DI: 07290117353547
·
Model: Set Screw
·
CARBOFIX ORTHOPEDICS LTD
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
2
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- CarboClear Hybrid Pedicle Screw System
- Primary DI
- 07290117353547
- Version / Model
- Set Screw
- Catalog Number
- HYB4000
- Company Name
- CARBOFIX ORTHOPEDICS LTD
- Labeler DUNS
- 649185170
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2024-07-14
- Public Version
- 3
- Public Version Date
- 2025-07-14
- Public Version Status
- Update
- Public Device Record Key
- 8e36c2ea-3179-45ff-a6bc-836096c32881
Device Description
Set Screw for use as part of the CarboClear Hybrid Pedicle Screw System
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | 888.3070 | 2 |
| PML | Bone Cement, Posterior Screw Augmentation | Orthopedic | 888.3027 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65553 | Spinal bone set screw | A small, implantable, non-bioabsorbable disc, threaded on its outside surface, intended to be threaded into the internal proximal end of a spinal bone screw head/rod adaptor, anchor, connector and/or hook (none included) to secure/stabilize a rod and/or tether as part of an internal spinal fixation procedure or a treatment for idiopathic scoliosis. It is made of metal (e.g., surgical steel, titanium alloy). | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 17290117353544 | GS1 | 2 | In Commercial Distribution | ||
| Primary | 07290117353547 | GS1 | ||||
| Unit of Use | 27290117353541 | GS1 |
Customer Contacts
- Phone
- 1-800-408-0120
- [email protected]
- Phone
- +97299511511
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240846 | 000 |