K210716 is an FDA 510(k) clearance for the CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments. This device is classified as a Thoracolumbosacral Pedicle Screw System (Class II - Special Controls, product code NKB).
Submitted by CarboFix Orthopedics , Ltd. (Herzeliya, IL). The FDA issued a Cleared decision on April 6, 2021, 27 days after receiving the submission on March 10, 2021.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3070. Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion..
| 510(k) Number | K210716 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 2021 |
| Decision Date | April 06, 2021 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | NKB — Thoracolumbosacral Pedicle Screw System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3070 |
| Definition | Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion. |