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510(k) K251961

SDS Growing Rod by BAAT Medical Products B.V. — Product Code PGM

K251961 is an FDA 510(k) premarket notification submitted by BAAT Medical Products B.V. for the device "SDS Growing Rod". The FDA issued a decision of Substantially Equivalent on January 15, 2026. The device falls under product code PGM (Growing Rod System), a Class II device regulated under 21 CFR 888.3070. BAAT Medical Products B.V. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2026
Date Received
June 26, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Growing Rod System
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Stabilization or correction of spinal deformities without the use of fusion.

Other clearances by BAAT Medical Products B.V.

  • K254176 — SINEFIX (March 16, 2026)
  • K220966 — SINEFIX (March 8, 2023)
  • K211474 — Kleiner KG2 System (September 14, 2021)
  • K201830 — ANSER Clavicle Pin (August 27, 2020)

Other clearances for product code PGM

  • K241816 — VerteGlide Spinal Growth Guidance System (March 14, 2025)
  • K213196 — MARVEL™ Growing Rods (December 19, 2022)
  • K193224 — Daytona® Small Stature Growth Rod Conversion Set (February 13, 2020)
  • K191212 — CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fen (September 24, 2019)
  • K181068 — CREO® Stabilization System, REVERE® Stabilization System (June 29, 2018)
  • K180227 — Polaris Spinal Growth System (March 15, 2018)
  • K172979 — NuVasive® Growth Rod Conversion Set (November 6, 2017)
  • K161028 — K2M Growing Spine System (July 22, 2016)
  • K150200 — CD HORIZON Growth Rod Conversion Set (February 25, 2015)
  • K142114 — Xia® Growth Rod Conversion Set (October 27, 2014)

FDA data resources