FDA Product Code
FDA Product Code PGM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3070
510(k) Clearances — 14 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251961 | SDS Growing Rod | BAAT Medical Products B.V. | 2026-01-15 | Traditional | PDF ↗ |
| K241816 | VerteGlide Spinal Growth Guidance System | OrthoPediatrics Corp. | 2025-03-14 | Traditional | PDF ↗ |
| K213196 | MARVEL Growing Rods | Globus Medical, Inc. | 2022-12-19 | Traditional | PDF ↗ |
| K193224 | Daytona® Small Stature Growth Rod Conversion Set | SeaSpine Orthopedics Corporation | 2020-02-13 | Traditional | PDF ↗ |
| 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, 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 System | Medos International SARL | 2019-09-24 | Traditional | PDF ↗ |
| K181068 | CREO® Stabilization System, REVERE® Stabilization System | Globus Medical, Inc. | 2018-06-29 | Traditional | PDF ↗ |
| K180227 | Polaris Spinal Growth System | Zimmer Biomet Spine, Inc. | 2018-03-15 | Traditional | PDF ↗ |
| K172979 | NuVasive® Growth Rod Conversion Set | Nu Vasive, Incorporated | 2017-11-06 | Traditional | PDF ↗ |
| K161028 | K2M Growing Spine System | K2m, Inc. | 2016-07-22 | Traditional | PDF ↗ |
| K150200 | CD HORIZON Growth Rod Conversion Set | Medtronic Sofamor Danek USA, Incorporated | 2015-02-25 | Special | PDF ↗ |
| K142114 | Xia® Growth Rod Conversion Set | Stryker Corporation | 2014-10-27 | Traditional | PDF ↗ |
| K141509 | ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS | Medos Sarl | 2014-08-22 | Traditional | PDF ↗ |
| K140750 | SHILLA GROWTH GUIDANCE SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2014-07-17 | Traditional | PDF ↗ |
| K133904 | CD HORIZON SPINAL SYSTEM GROWTH ROD SET | Medtronic Sofamor Danek USA | 2014-02-25 | Traditional | PDF ↗ |
Product code PGM · Class II · Orthopedic. Data: openFDA.