Daytona Small Stature
Rod Connector, 3.5 x 4.5, Small Stature
7manufacturers in China registered for this device type
44catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Shandong (2), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Seaspine Orthopedics Corporation, United States |
|---|---|
| FDA product code | OSH |
| Device type | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K180686 |
| Record published | 2018-06-23 |
| Record revised | 2025-10-24 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 76-0156 | 5.25 x 6.5mm | In distribution |
| 76-0178 | 6.5 x 8.0mm | In distribution |
| 76-0136 | 4.0 x 6.5mm, Left | In distribution |
| 76-0118 | 4.0 x 8.0mm, Left | In distribution |
| 76-0412 | 12.0 x 12.0mm | In distribution |
| 76-0044 | 3.5 x 4.5 | In distribution |
| 76-3500 | 4.0 x 500mm | In distribution |
| 76-0166 | 6.5 x 6.5mm | In distribution |
| 76-0155 | 5.25 x 5.5mm | In distribution |
| 76-0128 | 4.0 x 8.0mm, Right | In distribution |
| 76-3040 | 4.0 x 40mm | In distribution |
| 76-0157 | 5.25 x 7.5mm | In distribution |
| 76-0148 | 4.0 x 8.0mm, Right | In distribution |
| 76-0138 | 4.0 x 8.0mm, Left | In distribution |
| 76-3035 | 4.0 x 35mm | In distribution |
| 76-0188 | 8.0 x 8.0mm | In distribution |
| 76-0135 | 4.0 x 5.5mm, Left | In distribution |
| 76-3050 | 4.0 x 50mm | In distribution |
| 76-3100 | 4.0 x 100mm | In distribution |
| 76-0145 | 4.0 x 5.5mm, Right | In distribution |
| 76-0032 | Ti Locking Cap Asm. 4.0mm Small Stature | In distribution |
| 76-0116 | 4.0 x 6.5mm, Left | In distribution |
| 76-0134 | 4.0 x 4.25mm, Left | In distribution |
| 76-0126 | 4.0 x 6.5mm, Right | In distribution |
| 76-3140 | 4.0 x 140mm | In distribution |
| 76-3120 | 4.0 x 120mm | In distribution |
| 76-0106 | 4.0 x 6.5mm | In distribution |
| 76-0418 | 12.0 x 8.0mm | In distribution |
| 76-0108 | 4.0 x 8.0mm | In distribution |
| 76-3130 | 4.0 x 130mm | In distribution |
| 76-3250 | 4.0 x 250mm | In distribution |
| 76-0230 | 4.5 x 30mm | In distribution |
| 76-3300 | 4.0 x 300mm | In distribution |
| 76-0062 | 4.5 x 4.5mm | In distribution |
| 76-3090 | 4.0 x 90mm | In distribution |
| 76-0104 | 4.0 x 4.25mm | In distribution |
| 76-0406 | 10.0 x 6.5mm | In distribution |
| 76-0144 | 4.0 x 4.25mm, Right | In distribution |
| 76-0167 | 6.5 x 7.5mm | In distribution |
| 76-0146 | 4.0 x 6.5mm, Right | In distribution |
| 76-0125 | 4.0 x 5.5mm, Right | In distribution |
| 76-0228 | 4.5 x 28mm | In distribution |
| 76-3600 | 4.0 x 600mm | In distribution |
| 76-0175 | 6.5 x 5.5mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Creo | Globus Medical, Inc. | 1,821 |
| ReLine | Nuvasive, Inc. | 1,093 |
| Olympic | Astura Medical | 951 |
| Nex-D2 | Next Orthosurgical | 887 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 876 |
| Arsenal | Alphatec Spine, Inc. | 820 |
| Apex-DL Spine System | Spinecraft LLC | 691 |
| Polaris™ 4.75 Spinal System | Biomet Spine | 413 |
| Expedium | Medos International Sàrl | 400 |
| Implanet Spine System | Implanet | 386 |
| Everest® Spinal System | VB Spine LLC | 299 |
| Arsenal Deformity Spinal Fixation System | Alphatec Spine, Inc. | 258 |
Showing 12 of 73. All products under Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
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.