K241663 is an FDA 510(k) clearance for the Eminent Spine 3D Titanium Pedicle Screw System. This device is classified as a Thoracolumbosacral Pedicle Screw System (Class II - Special Controls, product code NKB).
Submitted by Eminent Spine (Plano, US). The FDA issued a Cleared decision on April 28, 2025, 325 days after receiving the submission on June 7, 2024.
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 | K241663 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 2024 |
| Decision Date | April 28, 2025 |
| Days to Decision | 325 days |
| Submission Type | Traditional |
| 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. |