Product code PGM
- Device name
- Growing Rod System
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3070
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Stabilization or correction of spinal deformities without the use of fusion.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251961 | SDS Growing Rod | BAAT Medical Products B.V. | 2026-01-15 |
| K241816 | VerteGlide Spinal Growth Guidance System | OrthoPediatrics Corp. | 2025-03-14 |
| K213196 | MARVEL™ Growing Rods | Globus Medical, Inc. | 2022-12-19 |
| K193224 | Daytona® Small Stature Growth Rod Conversion Set | SeaSpine Orthopedics Corporation | 2020-02-13 |
| K191212 | CrossOver 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, MONA... | Medos International SARL | 2019-09-24 |
| K181068 | CREO® Stabilization System, REVERE® Stabilization System | Globus Medical, Inc. | 2018-06-29 |
| K180227 | Polaris Spinal Growth System | Zimmer Biomet Spine, Inc. | 2018-03-15 |
| K172979 | NuVasive® Growth Rod Conversion Set | Nu Vasive, Incorporated | 2017-11-06 |
| K161028 | K2M Growing Spine System | K2m, Inc. | 2016-07-22 |
| K150200 | CD HORIZON Growth Rod Conversion Set | Medtronic Sofamor Danek USA, Incorporated | 2015-02-25 |
| K142114 | Xia® Growth Rod Conversion Set | Stryker Corporation | 2014-10-27 |
| K141509 | ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS | Medos Sarl | 2014-08-22 |
| K140750 | SHILLA GROWTH GUIDANCE SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2014-07-17 |
| K133904 | CD HORIZON SPINAL SYSTEM GROWTH ROD SET | Medtronic Sofamor Danek USA | 2014-02-25 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00763000873714 | MSB SHILLA Growth Guidance System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-07-04 |
| 00763000875176 | MSB SHILLA Growth Guidance System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-07-04 |
| 00763000874308 | SHILLA™ Growth Guidance System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-05-07 |
| 00763000874315 | SHILLA™ Growth Guidance System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-05-07 |
| 08720629951324 | SDS Growing Rod | Baat Medical Products B.V. | 2026-03-30 |
| 08720629958828 | SDS Growing Rod | Baat Medical Products B.V. | 2026-03-30 |
| 08720629958774 | SDS Growing Rod | Baat Medical Products B.V. | 2026-03-30 |
| 08720629958767 | SDS Growing Rod | Baat Medical Products B.V. | 2026-03-30 |
| 08720629958750 | SDS Growing Rod | Baat Medical Products B.V. | 2026-03-30 |
| 08720629951508 | SDS Growing Rod | Baat Medical Products B.V. | 2026-03-30 |
| 08720629951492 | SDS Growing Rod | Baat Medical Products B.V. | 2026-03-30 |
| 08720629951485 | SDS Growing Rod | Baat Medical Products B.V. | 2026-03-30 |
| 08720629951478 | SDS Growing Rod | Baat Medical Products B.V. | 2026-03-30 |
| 08720629951300 | SDS Growing Rod | Baat Medical Products B.V. | 2026-03-30 |
| 08720629951287 | SDS Growing Rod | Baat Medical Products B.V. | 2026-03-30 |
| 08720629951256 | SDS Growing Rod | Baat Medical Products B.V. | 2026-03-30 |
| 00763000874070 | SHILLA™ Growth Guidance System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-02-21 |
| 00763000874339 | SHILLA™ Growth Guidance System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-02-12 |
| 00763000874568 | SHILLA™ Growth Guidance System | MEDTRONIC SOFAMOR DANEK, INC. | 2025-11-20 |
| 00763000874742 | SHILLA™ Growth Guidance System | MEDTRONIC SOFAMOR DANEK, INC. | 2025-10-05 |
| 00763000874827 | SHILLA™ Growth Guidance System | MEDTRONIC SOFAMOR DANEK, INC. | 2025-10-05 |
| 00763000875213 | SHILLA™ Growth Guidance System | MEDTRONIC SOFAMOR DANEK, INC. | 2025-10-05 |
| 00763000875237 | SHILLA™ Growth Guidance System | MEDTRONIC SOFAMOR DANEK, INC. | 2025-10-05 |
| 00763000874445 | SHILLA™ Growth Guidance System | MEDTRONIC SOFAMOR DANEK, INC. | 2025-10-04 |
| 00763000875183 | SHILLA™ Growth Guidance System | MEDTRONIC SOFAMOR DANEK, INC. | 2025-10-03 |
| 20643169549771 | CD HORIZON® Growth Rod Conversion Set | MEDTRONIC SOFAMOR DANEK, INC. | 2024-12-23 |
| 07613327291469 | XIA | Stryker Corporation | 2016-03-18 |
| 07613327291452 | XIA | Stryker Corporation | 2016-03-18 |
| 07613327066265 | XIA | Stryker Corporation | 2016-03-18 |
| 07613327066210 | XIA | Stryker Corporation | 2016-03-18 |