FDA UDI
In Commercial Distribution
🇺🇸 United States
CarboClear Pedicle Screw System
DI: 07290109336565
·
Model: Locking Element R45
·
CARBOFIX ORTHOPEDICS LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2
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Basic Information
- Brand Name
- CarboClear Pedicle Screw System
- Primary DI
- 07290109336565
- Version / Model
- Locking Element R45
- Catalog Number
- PNNCCR3000
- Company Name
- CARBOFIX ORTHOPEDICS LTD
- Labeler DUNS
- 649185170
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2018-07-24
- Public Version
- 4
- Public Version Date
- 2025-07-02
- Public Version Status
- Update
- Public Device Record Key
- 79b98694-0e0f-4722-ae9f-e4d72e452347
Device Description
Locking Element (oncology) for use as part of the CarboClear 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66948 | Spinal bone screw head/rod adaptor | A small, implantable, non-bioabsorbable device intended to be attached to the top end of a spinal screw (not included) typically to secure/stabilize a rod and/or connector as part of an internal spinal fixation procedure. Also known as a reduction head or tulip, it is typically U-shaped with threads to receive a set screw and/or has a hole to allow the rod and/or connector to pass through; it may also facilitate a degree of motion. It is available in various lengths and is made of metal (e.g., surgical steel, titanium alloy) and/or synthetic polymer materials. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 17290109336562 | GS1 | 2 | In Commercial Distribution | ||
| Primary | 07290109336565 | GS1 | ||||
| Unit of Use | 27290109336569 | GS1 |
Customer Contacts
- Phone
- +97299511511
- [email protected]
- Phone
- 1-800-408-0120
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173487 | 000 |