XIA 3
Small Thoracic Laminar Hook Narrow Blade
7manufacturers in China registered for this device type
76catalogue 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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | OSH |
| Device type | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2014-12-08 |
| Record revised | 2024-09-11 (version 10) |
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, manufacturing date |
| Sizes | Length 20 to 130 mm |
| Distribution end date | 2024-06-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 482367055 | Diameter: 7.0 Millimeter | In distribution |
| 482304535 | Diameter: 4.5 Millimeter | In distribution |
| 482306080 | Length 80.0 mm | In distribution |
| 4823715550 | Length 50.0 mm | In distribution |
| 4823718560 | Length 60.0 mm | In distribution |
| 482306030 | Length 30.0 mm | In distribution |
| 482307540 | Diameter: 7.5 Millimeter | In distribution |
| 48230218 | In distribution | |
| 4823716565 | Diameter: 6.5 Millimeter | In distribution |
| 482315020 | Length 20.0 mm | In distribution |
| 48239120 | Length 120.0 mm | In distribution |
| 482305525 | Diameter: 5.5 Millimeter | In distribution |
| 482306530 | Length 30.0 mm | In distribution |
| 482316550 | Diameter: 6.5 Millimeter | In distribution |
| 4823716550 | Length 50.0 mm | In distribution |
| 48233645 | Diameter: 6.5 Millimeter | In distribution |
| 48233750 | Diameter: 7.5 Millimeter | In distribution |
| 48233760 | Diameter: 7.5 Millimeter | In distribution |
| 482304545 | Diameter: 4.5 Millimeter | In distribution |
| 482377560 | Diameter: 7.5 Millimeter | In distribution |
| 482365555 | Length 55.0 mm | In distribution |
| 482305555 | Length 55.0 mm | In distribution |
| 482337060 | Diameter: 7.0 Millimeter | In distribution |
| 482307560 | Diameter: 7.5 Millimeter | In distribution |
| 48230201 | In distribution | |
| 482316555 | Diameter: 6.5 Millimeter | In distribution |
| 482306555 | Length 55.0 mm | In distribution |
| 482387530 | Length 30.0 mm | In distribution |
| 4823717550 | Length 50.0 mm | In distribution |
| 48238100 | Diameter: 6.0 Millimeter | In distribution |
| 482306590 | Length 90.0 mm | In distribution |
| 482305535 | Length 35.0 mm | In distribution |
| 482366040 | Length 40.0 mm | In distribution |
| 482317050 | Diameter: 7.0 Millimeter | In distribution |
| 482307535 | Diameter: 7.5 Millimeter | In distribution |
| 482364530 | Length 30.0 mm | In distribution |
| 482307555 | Diameter: 7.5 Millimeter | In distribution |
| 482385550 | Diameter: 5.5 Millimeter | In distribution |
| 482384025 | Diameter: 4.0 Millimeter | In distribution |
| 48238080 | Length 80.0 mm | In distribution |
| 48233535 | Length 35.0 mm | In distribution |
| 482307070 | Diameter: 7.0 Millimeter | In distribution |
| 482367540 | Diameter: 7.5 Millimeter | In distribution |
| 482317550 | Diameter: 7.5 Millimeter | In distribution |
| 482384535 | Diameter: 4.5 Millimeter | In distribution |
| 48232120 | Diameter: 6.0 Millimeter | In distribution |
| 482304030 | Diameter: 4.0 Millimeter | In distribution |
| 482307550 | Length 50.0 mm | In distribution |
| 482307525 | Length 25.0 mm | In distribution |
| 48230216 | In distribution | |
| 482377530 | Diameter: 7.5 Millimeter | In distribution |
| 48239080 | Diameter: 6.0 Millimeter | In distribution |
| 482336045 | Length 45.0 mm | In distribution |
| 482304020 | Diameter: 4.0 Millimeter | In distribution |
| 48236020 | Length 20.0 mm | In distribution |
| 482315035 | Length 35.0 mm | In distribution |
| 482379580 | Length 80.0 mm | In distribution |
| 482378590 | Length 90.0 mm | In distribution |
| 482386560 | Diameter: 6.5 Millimeter | In distribution |
| 482306565 | Length 65.0 mm | In distribution |
| 482376565 | Diameter: 6.5 Millimeter | In distribution |
| 482314520 | Length 20.0 mm | In distribution |
| 4823717530 | Length 30.0 mm | In distribution |
| 482336035 | Diameter: 6.0 Millimeter | In distribution |
| 482387555 | Length 55.0 mm | In distribution |
| 482336055 | Length 55.0 mm | In distribution |
| 482367530 | Diameter: 7.5 Millimeter | In distribution |
| 482337030 | Length 30.0 mm | In distribution |
| 48232130 | Diameter: 6.0 Millimeter | In distribution |
| 482317065 | Diameter: 7.0 Millimeter | In distribution |
| 48233060 | Length 60.0 mm | In distribution |
| 482329590 | Length 90.0 mm | Withdrawn |
| 482327535 | Length 35.0 mm | Withdrawn |
| 482397500 | Length 100.0 mm | Withdrawn |
| 482326560 | Length 60.0 mm | Withdrawn |
| 482326570 | Length 70.0 mm | Withdrawn |
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.