PGM — Growing Rod System Class II
Classification Details
- Product Code
- PGM
- Device Class
- Class II
- Regulation Number
- 888.3070
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Definition
Stabilization or correction of spinal deformities without the use of fusion.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251961 | baat medical products | SDS Growing Rod | January 15, 2026 |
| K241816 | orthopediatrics | VerteGlide Spinal Growth Guidance System | March 14, 2025 |
| K213196 | globus medical | MARVEL Growing Rods | December 19, 2022 |
| K193224 | seaspine orthopedics corporation | Daytona® Small Stature Growth Rod Conversion Set | February 13, 2020 |
| K191212 | medos international sarl | CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fen | September 24, 2019 |
| K181068 | globus medical | CREO® Stabilization System, REVERE® Stabilization System | June 29, 2018 |
| K180227 | zimmer biomet spine | Polaris Spinal Growth System | March 15, 2018 |
| K172979 | nu vasive, incorporated | NuVasive® Growth Rod Conversion Set | November 6, 2017 |
| K161028 | k2m | K2M Growing Spine System | July 22, 2016 |
| K150200 | medtronic sofamor danek usa, incorporated | CD HORIZON Growth Rod Conversion Set | February 25, 2015 |
| K142114 | stryker corporation | Xia® Growth Rod Conversion Set | October 27, 2014 |
| K141509 | medos sarl | ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS | August 22, 2014 |
| K140750 | medtronic sofamor danek usa | SHILLA GROWTH GUIDANCE SYSTEM | July 17, 2014 |
| K133904 | medtronic sofamor danek usa | CD HORIZON SPINAL SYSTEM GROWTH ROD SET | February 25, 2014 |