K251961 is an FDA 510(k) clearance for the SDS Growing Rod. This device is classified as a Growing Rod System (Class II - Special Controls, product code PGM).
Submitted by BAAT Medical Products B.V. (Hengelo, NL). The FDA issued a Cleared decision on January 15, 2026, 203 days after receiving the submission on June 26, 2025.
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 | K251961 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 2025 |
| Decision Date | January 15, 2026 |
| Days to Decision | 203 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. |