FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments
K Number: K210716
·
Decision Apr 6, 2021
Classifications
1
FEI Numbers
413
Registration Numbers
413
Same Product Code
873
Applicant Total
17
Review Days
27
Basic Information
- Device Name
- CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments
- K Number
- K210716
- 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 10, 2021
- Decision Date
- April 6, 2021
- 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 | ||
|---|---|---|---|
| K233793 | CarboClear® X Pedicle Screw System | Aug 1, 2024 | Substantially Equivalent |
| K240846 | 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 | Apr 25, 2024 | Substantially Equivalent |
| K233989 | CarboClear® Posterior Cervical Screw System | Mar 27, 2024 | Substantially Equivalent |
| K203317 | CarboClear X Pedicle Screw System | Nov 25, 2020 | Substantially Equivalent |
| K201926 | CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System | Aug 7, 2020 | Substantially Equivalent |
| K201251 | CarboClear Navigated Instruments | Aug 5, 2020 | Substantially Equivalent |
| K200519 | CarboClear® II Pedicle Screw System | Apr 30, 2020 | Substantially Equivalent |
| K193378 | CarboClear Lumbar Cage System | Mar 2, 2020 | Substantially Equivalent |
| K192214 | CarboClear VBR System | Oct 11, 2019 | Substantially Equivalent |
| K190526 | High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws | Sep 19, 2019 | Substantially Equivalent |