Panels › Orthopedic › Product code PGM · Class 2
Growing Rod System
Regulation 888.3070
1510(k)s in 12 months (14 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PGM
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Sofamor Danek USA | 3 | 0 |
| Globus Medical, Inc. | 2 | 0 |
| BAAT Medical Products B.V. | 1 | 0 |
| K2m, Inc. | 1 | 0 |
| Medos Sarl | 1 | 0 |
| Medos International SARL | 1 | 0 |
| Nu Vasive, Incorporated | 1 | 0 |
| OrthoPediatrics Corp. | 1 | 0 |
| SeaSpine Orthopedics Corporation | 1 | 0 |
| Stryker Corporation | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 15, 2026 | K251961 | SDS Growing Rod BAAT Medical Products B.V., NL | PGM |
| Mar 14, 2025 | K241816 | VerteGlide Spinal Growth Guidance System OrthoPediatrics Corp. | PGM |
| Dec 19, 2022 | K213196 | MARVEL Growing Rods Globus Medical, Inc. | PGM |
| Feb 13, 2020 | K193224 | Daytona® Small Stature Growth Rod Conversion Set SeaSpine Orthopedics Corporation | PGM |
| Sep 24, 2019 | K191212 | CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cros Medos International SARL, CH | PGM |
| Jun 29, 2018 | K181068 | CREO® Stabilization System, REVERE® Stabilization System Globus Medical, Inc. | PGM |
| Mar 15, 2018 | K180227 | Polaris Spinal Growth System Zimmer Biomet Spine, Inc. | PGM |
| Nov 6, 2017 | K172979 | NuVasive® Growth Rod Conversion Set Nu Vasive, Incorporated | PGM |
| Jul 22, 2016 | K161028 | K2M Growing Spine System K2m, Inc. | PGM |
| Feb 25, 2015 | K150200 | CD HORIZON Growth Rod Conversion Set Medtronic Sofamor Danek USA, Incorporated | PGM |
| Oct 27, 2014 | K142114 | Xia® Growth Rod Conversion Set Stryker Corporation | PGM |
| Aug 22, 2014 | K141509 | ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS Medos Sarl | PGM |
| Jul 17, 2014 | K140750 | SHILLA GROWTH GUIDANCE SYSTEM Medtronic Sofamor Danek USA, Inc. | PGM |
| Feb 25, 2014 | K133904 | CD HORIZON SPINAL SYSTEM GROWTH ROD SET Medtronic Sofamor Danek USA | PGM |
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