FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments
K Number: K233944
·
Decision Jan 10, 2024
Classifications
1
FEI Numbers
413
Registration Numbers
413
Same Product Code
873
Applicant Total
2
Review Days
27
Basic Information
- Device Name
- CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments
- K Number
- K233944
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CarboFix Orthopedics, Ltd.
- Date Received
- December 14, 2023
- Decision Date
- January 10, 2024
- Product Code
- NKB
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | FDA class 2 | Orthopedic |
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Other Clearances by CarboFix Orthopedics, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K201917 | Piccolo Composite Proximal Tibia Plate System | Oct 8, 2020 | Substantially Equivalent |