K241816 is an FDA 510(k) clearance for the VerteGlide Spinal Growth Guidance System. This device is classified as a Growing Rod System (Class II - Special Controls, product code PGM).
Submitted by OrthoPediatrics Corp. (Warsaw, US). The FDA issued a Cleared decision on March 14, 2025, 263 days after receiving the submission on June 24, 2024.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3070. Stabilization Or Correction Of Spinal Deformities Without The Use Of Fusion..
| 510(k) Number | K241816 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 2024 |
| Decision Date | March 14, 2025 |
| Days to Decision | 263 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | PGM — Growing Rod System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3070 |
| Definition | Stabilization Or Correction Of Spinal Deformities Without The Use Of Fusion. |