XIA
Growth Rod Connector, Large
1manufacturer
4catalogue numbers in this listing
1510(k) clearance
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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | PGM |
| Device type | Growing Rod System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2016-03-18 |
| Record revised | 2024-09-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Length 30 to 60 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 48139460S | Diameter: 4.5 Millimeter | In distribution |
| 48139430 | Length 30.0 mm | In distribution |
| 48139430S | Length 30.0 mm | In distribution |
| 48139460 | Diameter: 4.5 Millimeter | In distribution |
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 |
| Expedium | Depuy Spine, Inc. | 6 |
| MSB Shilla Growth Guidance System | Medtronic Sofamor Danek, Inc. | 5 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K142114 | 2014-10-27 |
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.