Growing Rod System
FDA product code PGM · Class II (moderate risk) · 21 CFR 888.3070 · Orthopedic
Stabilization or correction of spinal deformities without the use of fusion.
14510(k) clearances
0PMA approvals
0recalls
Implantimplanted device
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251961 | SDS Growing RodPGM · Traditional | BAAT Medical Products B.V. | 01/15/2026SE |
| K241816 | VerteGlide Spinal Growth Guidance SystemPGM · Traditional | OrthoPediatrics Corp. | 03/14/2025SE |
| K213196 | MARVEL Growing RodsPGM · Traditional | Globus Medical, Inc. | 12/19/2022SE |
| K193224 | Daytona® Small Stature Growth Rod Conversion SetPGM · Traditional | SeaSpine Orthopedics Corporation | 02/13/2020SE |
| K191212 | CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…PGM · Traditional | Medos International SARL | 09/24/2019SE |
| K181068 | CREO® Stabilization System, REVERE® Stabilization SystemPGM · Traditional | Globus Medical, Inc. | 06/29/2018SE |
| K180227 | Polaris Spinal Growth SystemPGM · Traditional | Zimmer Biomet Spine, Inc. | 03/15/2018SE |
| K172979 | NuVasive® Growth Rod Conversion SetPGM · Traditional | Nu Vasive, Incorporated | 11/06/2017SE |
| K161028 | K2M Growing Spine SystemPGM · Traditional | K2m, Inc. | 07/22/2016SE |
| K150200 | CD HORIZON Growth Rod Conversion SetPGM · Special | Medtronic Sofamor Danek USA, Incorporated | 02/25/2015SE |
| K142114 | Xia® Growth Rod Conversion SetPGM · Traditional | Stryker Corporation | 10/27/2014SE |
| K141509 | Isola and Expedium Growing Spine SystemsPGM · Traditional | Medos Sarl | 08/22/2014SE |
| K140750 | Shilla Growth Guidance SystemPGM · Traditional | Medtronic Sofamor Danek USA, Inc. | 07/17/2014SE |
| K133904 | CD Horizon Spinal System Growth Rod SetPGM · Traditional | Medtronic Sofamor Danek USA | 02/25/2014SE |