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CarboFix Orthopedics , Ltd. FDA Approvals
0 new drug approvals and 9 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System510(k)Mar 16, 2026Orthopedic |
| CarboClear® Hybrid Pedicle Screw System510(k)Nov 5, 2024Orthopedic |
| CarboClear® X Pedicle Screw System510(k)Aug 1, 2024Orthopedic |
| 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 Cement510(k)Apr 25, 2024Orthopedic |
| CarboClear® Posterior Cervical Screw System510(k)Mar 27, 2024Orthopedic |
| CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments510(k)Jan 10, 2024Orthopedic |
| CarboClear® Pedicle Screw System510(k)Oct 10, 2023Orthopedic |
| CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement510(k)Jul 3, 2023Orthopedic |
| CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments510(k)Apr 6, 2021Orthopedic |