FDA.reportPublic FDA data

510(k) K251961

Device
SDS Growing Rod
Applicant
BAAT Medical Products B.V.
510(k) number
K251961
Product code
PGM
Decision
Substantially Equivalent (SESE)
Decision date
2026-01-15
Date received
2025-06-26
Regulation
888.3070
Classification name
Growing Rod System
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Jasper Springer
Address
F. Hazemeijerstraat 800 Bldg. A04 Hengelo NL 7555 RJ 7555 RJ

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PGM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K241816VerteGlide Spinal Growth Guidance SystemOrthoPediatrics Corp.2025-03-14
K213196MARVEL™ Growing RodsGlobus Medical, Inc.2022-12-19
K193224Daytona® Small Stature Growth Rod Conversion SetSeaSpine Orthopedics Corporation2020-02-13
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 SARL2019-09-24
K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.2018-06-29
K180227Polaris Spinal Growth SystemZimmer Biomet Spine, Inc.2018-03-15
K172979NuVasive® Growth Rod Conversion SetNu Vasive, Incorporated2017-11-06
K161028K2M Growing Spine SystemK2m, Inc.2016-07-22
K150200CD HORIZON Growth Rod Conversion SetMedtronic Sofamor Danek USA, Incorporated2015-02-25
K142114Xia® Growth Rod Conversion SetStryker Corporation2014-10-27
K141509ISOLA AND EXPEDIUM GROWING SPINE SYSTEMSMedos Sarl2014-08-22
K140750SHILLA GROWTH GUIDANCE SYSTEMMedtronic Sofamor Danek USA, Inc.2014-07-17
K133904CD HORIZON SPINAL SYSTEM GROWTH ROD SETMedtronic Sofamor Danek USA2014-02-25