Decision Date2026-01-15
Product CodePGM
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
SDS Growing Rod is a medical device manufactured by BAAT Medical Products B.V.. It received FDA 510(k) clearance on 2026-01-15 under approval number K251961. The device is classified under product code PGM. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SDS Growing Rod?
SDS Growing Rod is a medical device that received FDA 510(k) clearance on 2026-01-15. It is manufactured by BAAT Medical Products B.V.. The 510(k) number is K251961.
When was SDS Growing Rod approved by the FDA?
SDS Growing Rod received FDA 510(k) clearance on 2026-01-15, under approval number K251961.
What company makes SDS Growing Rod?
SDS Growing Rod is manufactured by BAAT Medical Products B.V..
What is the FDA product code for SDS Growing Rod?
The FDA product code for SDS Growing Rod is PGM.
Other Devices by BAAT Medical Products B.V.
Related Devices (Code: PGM)
K161028K2M Growing Spine SystemK2m, Inc.
K172979NuVasive® Growth Rod Conversion SetNu Vasive, Incorporated
K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.
K180227Polaris Spinal Growth SystemZimmer Biomet Spine, Inc.
K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine SystemMedos International SARL
K193224Daytona® Small Stature Growth Rod Conversion SetSeaSpine Orthopedics Corporation
Official Source
View on FDA Database →
Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.