510(k) K191212
- Device
- 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 Sys
- Applicant
- Medos International SARL
- 510(k) number
- K191212
- Product code
- PGM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-09-24
- Date received
- 2019-05-06
- Regulation
- 510(k) Premarket Notification
- Classification name
- Growing Rod System
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Sergio M. Cordeiro
- Address
- Chemin-Blanc 38 Lelocle CH 2400 2400
FDA Registration Numbers#
- 3030412764
- 3014725904
- 3010386387
- 3004188066
- 1030489
- 3003525643
- 3004464325
- 1531174
- 3009010435
- 3012447612
- 3008868758
- 3012120772
- 1526534
- 3018094310
- 3003761012
- 3000270450
- 2647346
- 3010041430
- 3006984710
- 1824199
- 3006460162
- 3010440433
- 1526439
- 3009973699
- 3004774118
- 3014252644
- 2183946
- 3010363503
- 3004024955
- 3003120897
- 2531477
- 3015216945
- 3009417901
- 3008114965
- 3010370500
- 3009144915
- 3016050940
- 2031966
- 9617544
- 3004142400
- 3010047454
- 3007344102
Source Documents#
Other 510(k) Records For Product Code PGM #
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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