Expedium
EXPEDIUM SPINE SYSTEM EXTENDED TANDEM CONNECTOR 4.5 - 4.5 x 80mm
1manufacturer
6catalogue numbers in this listing
Who Else Makes It
Registered in Fujian.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Record
| Listed by | Depuy Spine, Inc., United States |
|---|---|
| FDA product code | PGM |
| Device type | Growing Rod System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K141509 |
| Record published | 2016-11-08 |
| Record revised | 2025-07-02 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2019-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 186172680 | In distribution | |
| 186172660 | In distribution | |
| 186172640 | In distribution | |
| 186272680 | Withdrawn | |
| 186272640 | Withdrawn | |
| 186272660 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| VerteGlide Spinal Growth Guidance System | Orthopediatrics, Corp | 204 |
| CD Horizon® Growth Rod Conversion Set | Medtronic Sofamor Danek, Inc. | 37 |
| Shilla™ Growth Guidance System | Medtronic Sofamor Danek, Inc. | 23 |
| SDS Growing Rod | Baat Medical Products B.V. | 12 |
| Daytona® Small Stature | Seaspine Orthopedics Corporation | 8 |
| MSB Shilla Growth Guidance System | Medtronic Sofamor Danek, Inc. | 5 |
| XIA | Stryker GmbH | 4 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.