Cleared Traditional

SDS Growing Rod

K251961 · BAAT Medical Products B.V. · Orthopedic
Jan 2026
Decision
203d
Days
Class 2
Risk

About This 510(k) Submission

K251961 is an FDA 510(k) clearance for the SDS Growing Rod, 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 review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K251961 FDA.gov
FDA Decision Cleared 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

Device Classification

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.

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