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
FDA 510(k) clearance K240846 · decided 2024-04-25
Clearance details
- K-number
- K240846
- 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
- Applicant
- CarboFix Orthopedics , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-03-27
- Decision date
- 2024-04-25
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Herzeliya, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.