FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement
K Number: K240846
·
Decision Apr 25, 2024
Classifications
1
FEI Numbers
407
Registration Numbers
407
Same Product Code
900
Applicant Total
32
Review Days
29
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Basic Information
- Device Name
- CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement
- K Number
- K240846
- 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
- March 27, 2024
- Decision Date
- April 25, 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 | ||
|---|---|---|---|
| K254045 | CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System | Mar 16, 2026 | Substantially Equivalent |
| K243106 | CarboClear® Hybrid Pedicle Screw System | Nov 5, 2024 | Substantially Equivalent |
| K233793 | CarboClear® X Pedicle Screw System | Aug 1, 2024 | Substantially Equivalent |
| K233989 | CarboClear® Posterior Cervical Screw System | Mar 27, 2024 | Substantially Equivalent |
| K233944 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments | Jan 10, 2024 | Substantially Equivalent |
| K232341 | CarboClear® Pedicle Screw System | Oct 10, 2023 | Substantially Equivalent |
| K231280 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement | Jul 3, 2023 | Substantially Equivalent |
| K210716 | CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments | Apr 6, 2021 | Substantially Equivalent |
| K203317 | CarboClear X Pedicle Screw System | Nov 25, 2020 | Substantially Equivalent |
| K201917 | Piccolo Composite Proximal Tibia Plate System | Oct 8, 2020 | Substantially Equivalent |