Daytona® Small Stature
Ext. Axial Connector 2-Screw, 50mm, 3mm OZAT
1manufacturer
8catalogue 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 | Seaspine Orthopedics Corporation, United States |
|---|---|
| FDA product code | PGM |
| Device type | Growing Rod System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K193224 |
| Record published | 2020-08-12 |
| Record revised | 2025-10-24 (version 4) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 76-0300 | In distribution | |
| 76-0313 | In distribution | |
| 76-0302 | In distribution | |
| 97-6501 | In distribution | |
| 76-0303 | In distribution | |
| 76-0311 | In distribution | |
| 76-0312 | In distribution | |
| 76-0301 | 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 |
| Expedium | Depuy Spine, Inc. | 6 |
| MSB Shilla Growth Guidance System | Medtronic Sofamor Danek, Inc. | 5 |
| XIA | Stryker GmbH | 4 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K193224 | 2020-02-13 |
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.