Arsenal Deformity Spinal Fixation System
15° Offset Narrow Blade Transverse Process Hook, Left, 9.5mm
7manufacturers in China registered for this device type
258catalogue 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 | Alphatec Spine, Inc., 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, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K152968 |
| Record published | 2016-04-27 |
| Record revised | 2024-09-11 (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 |
| Sizes | Outer diameter 3.5 to 10.5 mm; length 18 to 200 mm; angle 10 to 50 ° |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 48700-025-095-030 | Outer Diameter 9.5 mm | In distribution |
| 48800-050-050 | Outer Diameter 5 mm | In distribution |
| 48700-010-105-090 | Outer Diameter 10.5 mm | In distribution |
| 48700-025-070-100 | Outer Diameter 7 mm | In distribution |
| 48001-045-18 | Length 18 mm | In distribution |
| 48700-020-065-120 | Length 120 mm | In distribution |
| 48700-020-065-020 | Outer Diameter 6.5 mm | In distribution |
| 48700-030-070-105 | Angle 30 ° | In distribution |
| 48700-025-065-110 | Outer Diameter 6.5 mm | In distribution |
| 48700-020-105-045 | Outer Diameter 10.5 mm | In distribution |
| 48700-030-080-125 | Length 125 mm | In distribution |
| 48001-35-28 | Outer Diameter 3.5 mm | In distribution |
| 48700-015-100-080 | Length 80 mm | In distribution |
| 48700-015-075-100 | Outer Diameter 7.5 mm | In distribution |
| 48700-025-075-085 | Outer Diameter 7.5 mm | In distribution |
| 48700-020-100-085 | Outer Diameter 10 mm | In distribution |
| 48700-015-085-055 | Outer Diameter 8.5 mm | In distribution |
| 48700-010-075-090 | Outer Diameter 7.5 mm | In distribution |
| 48800-040-040 | Outer Diameter 4 mm | In distribution |
| 48700-020-070-120 | Outer Diameter 7 mm | In distribution |
| 48700-015-070-075 | Outer Diameter 7 mm | In distribution |
| 48700-030-085-070 | Outer Diameter 8.5 mm | In distribution |
| 48700-030-085-060 | Outer Diameter 8.5 mm | In distribution |
| 48700-020-075-050 | Angle 20 ° | In distribution |
| 48700-025-070-030 | Outer Diameter 7 mm | In distribution |
| 48700-015-075-085 | Outer Diameter 7.5 mm | In distribution |
| 48700-025-085-120 | Outer Diameter 8.5 mm | In distribution |
| 48700-030-095-095 | Outer Diameter 9.5 mm | In distribution |
| 48700-010-090-125 | Outer Diameter 9 mm | In distribution |
| 48700-015-065-050 | Outer Diameter 6.5 mm | In distribution |
| 48700-030-065-075 | Outer Diameter 6.5 mm | In distribution |
| 48700-010-075-030 | Outer Diameter 7.5 mm | In distribution |
| 48001-045-28 | Length 28 mm | In distribution |
| 48700-010-105-115 | Outer Diameter 10.5 mm | In distribution |
| 48700-030-075-120 | Angle 30 ° | In distribution |
| 48700-025-070-085 | Outer Diameter 7 mm | In distribution |
| 48700-010-095-080 | Outer Diameter 9.5 mm | In distribution |
| 48700-020-100-065 | Outer Diameter 10 mm | In distribution |
| 48700-015-085-100 | Outer Diameter 8.5 mm | In distribution |
| 48700-020-095-075 | Outer Diameter 9.5 mm | In distribution |
| 48700-015-070-105 | Angle 15 ° | In distribution |
| 48700-010-090-040 | Outer Diameter 9 mm | In distribution |
| 48700-030-095-120 | Outer Diameter 9.5 mm | In distribution |
| 48700-030-065-085 | Length 85 mm | In distribution |
| 48700-010-095-035 | Outer Diameter 9.5 mm | In distribution |
| 48700-015-065-115 | Outer Diameter 6.5 mm | In distribution |
| 48700-015-070-030 | Outer Diameter 7 mm | In distribution |
| 48700-030-080-070 | Angle 30 ° | In distribution |
| 48700-030-095-040 | Angle 30 ° | In distribution |
| 48700-020-070-065 | Outer Diameter 7 mm | In distribution |
| 48700-030-065-080 | Angle 30 ° | In distribution |
| 48700-010-105-100 | Outer Diameter 10.5 mm | In distribution |
| 48700-020-095-095 | Outer Diameter 9.5 mm | In distribution |
| 48700-010-070-090 | Outer Diameter 7 mm | In distribution |
| 48700-010-075-075 | Outer Diameter 7.5 mm | In distribution |
| 48700-010-070-075 | Outer Diameter 7 mm | In distribution |
| 48700-010-090-030 | Outer Diameter 9 mm | In distribution |
| 48700-030-085-040 | Outer Diameter 8.5 mm | In distribution |
| 48700-010-105-045 | Angle 10 ° | In distribution |
| 48700-020-075-095 | Outer Diameter 7.5 mm | In distribution |
| 48700-025-100-075 | Outer Diameter 10 mm | In distribution |
| 48700-010-105-065 | Length 65 mm | In distribution |
| 48700-025-065-030 | Outer Diameter 6.5 mm | In distribution |
| 48700-015-095-090 | Outer Diameter 9.5 mm | In distribution |
| 48700-010-065-050 | Outer Diameter 6.5 mm | In distribution |
| 48700-025-075-050 | Angle 25 ° | In distribution |
| 48700-015-090-130 | Angle 15 ° | In distribution |
| 48700-025-090-085 | Outer Diameter 9 mm | In distribution |
| 48700-025-085-080 | Angle 25 ° | In distribution |
| 48700-010-080-055 | Angle 10 ° | In distribution |
| 48700-015-065-025 | Length 25 mm | In distribution |
| 48700-030-080-060 | Outer Diameter 8 mm | In distribution |
| 48700-015-065-020 | Outer Diameter 6.5 mm | In distribution |
| 48700-030-080-055 | Angle 30 ° | In distribution |
| 48700-020-090-120 | Outer Diameter 9 mm | In distribution |
| 48700-025-100-090 | Outer Diameter 10 mm | In distribution |
| 48700-025-100-095 | Length 95 mm | In distribution |
| 48700-020-085-105 | Outer Diameter 8.5 mm | In distribution |
| 48700-025-100-050 | Angle 25 ° | In distribution |
| 48700-010-085-035 | Outer Diameter 8.5 mm | In distribution |
| 48700-010-095-110 | Outer Diameter 9.5 mm | In distribution |
| 48700-025-075-095 | Outer Diameter 7.5 mm | In distribution |
| 48700-025-095-120 | Length 120 mm | In distribution |
| 48700-015-070-040 | Outer Diameter 7 mm | In distribution |
| 48700-025-085-125 | Length 125 mm | In distribution |
| 48700-015-105-035 | Outer Diameter 10.5 mm | In distribution |
| 48600-012-015-095 | Outer Diameter 9.5 mm | In distribution |
| 48022-55-050 | Angle 50 ° | In distribution |
| 48700-015-075-045 | Outer Diameter 7.5 mm | In distribution |
| 48700-010-080-105 | Outer Diameter 8 mm | In distribution |
| 48800-060-045 | Outer Diameter 6 mm | In distribution |
| 48700-030-070-130 | Angle 30 ° | In distribution |
| 48800-055-035 | Outer Diameter 5.5 mm | In distribution |
| 48700-015-100-050 | Length 50 mm | In distribution |
| 48001-040-26 | Outer Diameter 4 mm | In distribution |
| 48700-020-100-050 | Outer Diameter 10 mm | In distribution |
| 48700-020-095-060 | Outer Diameter 9.5 mm | In distribution |
| 48700-025-080-080 | Outer Diameter 8 mm | In distribution |
| 48700-025-090-125 | Angle 25 ° | In distribution |
| 48700-015-100-060 | Outer Diameter 10 mm | In distribution |
| 48700-010-075-120 | Outer Diameter 7.5 mm | In distribution |
| 48700-015-080-075 | Length 75 mm | In distribution |
| 48700-015-100-105 | Length 105 mm | In distribution |
| 48700-030-105-100 | Outer Diameter 10.5 mm | In distribution |
| 48700-015-105-095 | Outer Diameter 10.5 mm | In distribution |
| 48700-010-095-040 | Outer Diameter 9.5 mm | In distribution |
| 48700-015-105-030 | Outer Diameter 10.5 mm | In distribution |
| 48700-015-085-040 | Outer Diameter 8.5 mm | In distribution |
| 48700-025-095-075 | Outer Diameter 9.5 mm | In distribution |
| 48700-025-065-130 | Length 130 mm | In distribution |
| 48700-025-095-095 | Outer Diameter 9.5 mm | In distribution |
| 48700-030-090-090 | Outer Diameter 9 mm | In distribution |
| 48700-025-075-105 | Outer Diameter 7.5 mm | In distribution |
| 48700-020-090-035 | Length 35 mm | In distribution |
| 48700-020-070-090 | Outer Diameter 7 mm | In distribution |
| 48800-050-065 | Length 65 mm | In distribution |
| 48800-050-055 | Outer Diameter 5 mm | In distribution |
| 48700-030-065-100 | Outer Diameter 6.5 mm | In distribution |
| 48700-020-095-090 | Outer Diameter 9.5 mm | In distribution |
| 48700-020-095-070 | Outer Diameter 9.5 mm | In distribution |
| 48700-030-100-125 | Outer Diameter 10 mm | In distribution |
| 48700-015-065-090 | Outer Diameter 6.5 mm | In distribution |
| 48700-025-065-025 | Outer Diameter 6.5 mm | In distribution |
| 48700-020-065-025 | Outer Diameter 6.5 mm | In distribution |
| 48700-030-100-045 | Outer Diameter 10 mm | In distribution |
| 48700-030-080-075 | Outer Diameter 8 mm | In distribution |
| 48700-015-080-055 | Outer Diameter 8 mm | In distribution |
| 48700-020-065-035 | Outer Diameter 6.5 mm | In distribution |
| 48700-025-080-050 | Outer Diameter 8 mm | In distribution |
| 48700-020-105-090 | Outer Diameter 10.5 mm | In distribution |
| 48700-025-090-110 | Length 110 mm | In distribution |
| 48700-030-100-050 | Outer Diameter 10 mm | In distribution |
| 48700-015-085-030 | Outer Diameter 8.5 mm | In distribution |
| 48700-025-070-070 | Outer Diameter 7 mm | In distribution |
| 48700-030-105-055 | Outer Diameter 10.5 mm | In distribution |
| 48700-030-070-115 | Outer Diameter 7 mm | In distribution |
| 48700-030-075-075 | Outer Diameter 7.5 mm | In distribution |
| 48800-055-020 | Outer Diameter 5.5 mm | In distribution |
| 48700-020-080-090 | Angle 20 ° | In distribution |
| 48700-030-080-105 | Angle 30 ° | In distribution |
| 48700-015-105-100 | Outer Diameter 10.5 mm | In distribution |
| 48700-010-090-080 | Outer Diameter 9 mm | In distribution |
| 48700-010-090-075 | Outer Diameter 9 mm | In distribution |
| 48700-030-080-085 | Outer Diameter 8 mm | In distribution |
| 48700-010-090-090 | Outer Diameter 9 mm | In distribution |
| 48800-040-050 | Outer Diameter 4 mm | In distribution |
| 48700-020-075-080 | Outer Diameter 7.5 mm | In distribution |
| 48700-010-090-060 | Outer Diameter 9 mm | In distribution |
| 48700-015-065-045 | Outer Diameter 6.5 mm | In distribution |
| 48700-020-075-130 | Angle 20 ° | In distribution |
| 48700-020-065-090 | Outer Diameter 6.5 mm | In distribution |
| 48700-015-080-085 | Outer Diameter 8 mm | In distribution |
| 48700-020-075-075 | Outer Diameter 7.5 mm | In distribution |
| 48700-010-090-110 | Outer Diameter 9 mm | In distribution |
| 48700-030-065-115 | Angle 30 ° | In distribution |
| 48800-075-070 | Length 70 mm | In distribution |
| 48001-040-30 | Length 30 mm | In distribution |
| 48700-020-090-115 | Length 115 mm | In distribution |
| 48700-020-085-090 | Angle 20 ° | In distribution |
| 48700-010-090-130 | Outer Diameter 9 mm | In distribution |
| 48700-015-105-110 | Outer Diameter 10.5 mm | In distribution |
| 48700-020-065-065 | Outer Diameter 6.5 mm | In distribution |
| 48700-020-080-035 | Length 35 mm | In distribution |
| 48700-025-085-110 | Outer Diameter 8.5 mm | In distribution |
| 48700-015-095-030 | Outer Diameter 9.5 mm | In distribution |
| 48700-025-065-070 | Outer Diameter 6.5 mm | In distribution |
| 48700-030-065-065 | Length 65 mm | In distribution |
| 48700-020-095-105 | Outer Diameter 9.5 mm | In distribution |
| 48700-030-080-030 | Outer Diameter 8 mm | In distribution |
| 48700-020-065-045 | Outer Diameter 6.5 mm | In distribution |
| 48700-025-070-080 | Outer Diameter 7 mm | In distribution |
| 48700-010-100-055 | Outer Diameter 10 mm | In distribution |
| 48700-025-090-045 | Outer Diameter 9 mm | In distribution |
| 48700-020-070-100 | Outer Diameter 7 mm | In distribution |
| 48800-040-055 | Outer Diameter 4 mm | In distribution |
| 48700-030-065-045 | Outer Diameter 6.5 mm | In distribution |
| 48700-030-085-055 | Angle 30 ° | In distribution |
| 48700-020-070-055 | Outer Diameter 7 mm | In distribution |
| 48700-025-065-045 | Outer Diameter 6.5 mm | In distribution |
| 48700-015-065-120 | Outer Diameter 6.5 mm | In distribution |
| 48700-025-085-045 | Outer Diameter 8.5 mm | In distribution |
| 48700-010-095-070 | Outer Diameter 9.5 mm | In distribution |
| 48700-025-105-040 | Outer Diameter 10.5 mm | In distribution |
| 48700-030-085-115 | Outer Diameter 8.5 mm | In distribution |
| 48700-030-085-090 | Outer Diameter 8.5 mm | In distribution |
| 48700-015-070-065 | Outer Diameter 7 mm | In distribution |
| 48700-020-075-115 | Outer Diameter 7.5 mm | In distribution |
| 48700-015-075-110 | Outer Diameter 7.5 mm | In distribution |
| 48700-030-090-075 | Angle 30 ° | In distribution |
| 48700-010-080-060 | Outer Diameter 8 mm | In distribution |
| 48700-025-065-105 | Outer Diameter 6.5 mm | In distribution |
| 48700-020-080-055 | Outer Diameter 8 mm | In distribution |
| 48700-030-100-070 | Outer Diameter 10 mm | In distribution |
| 48700-010-080-065 | Outer Diameter 8 mm | In distribution |
| 48800-055-025 | Outer Diameter 5.5 mm | In distribution |
| 48700-010-085-045 | Outer Diameter 8.5 mm | In distribution |
| 48700-020-095-030 | Outer Diameter 9.5 mm | In distribution |
| 48700-010-075-110 | Outer Diameter 7.5 mm | In distribution |
| 48700-030-080-040 | Length 40 mm | In distribution |
| 48700-015-105-130 | Angle 15 ° | In distribution |
| 48700-020-095-045 | Outer Diameter 9.5 mm | In distribution |
| 48700-015-070-050 | Outer Diameter 7 mm | In distribution |
| 48700-025-080-130 | Outer Diameter 8 mm | In distribution |
| 48800-080-075 | Outer Diameter 8 mm | In distribution |
| 48700-025-075-075 | Outer Diameter 7.5 mm | In distribution |
| 48700-020-085-040 | Angle 20 ° | In distribution |
| 48700-025-070-055 | Outer Diameter 7 mm | In distribution |
| 48700-025-085-055 | Outer Diameter 8.5 mm | In distribution |
| 48700-020-075-110 | Angle 20 ° | In distribution |
| 48700-030-100-095 | Angle 30 ° | In distribution |
| 48700-030-065-050 | Outer Diameter 6.5 mm | In distribution |
| 48700-020-090-060 | Outer Diameter 9 mm | In distribution |
| 48700-025-075-080 | Outer Diameter 7.5 mm | In distribution |
| 48700-025-090-075 | Outer Diameter 9 mm | In distribution |
| 48700-030-085-080 | Angle 30 ° | In distribution |
| 48700-015-100-125 | Length 125 mm | In distribution |
| 48800-055-045 | Outer Diameter 5.5 mm | In distribution |
| 48700-030-100-035 | Angle 30 ° | In distribution |
| 48700-025-085-060 | Outer Diameter 8.5 mm | In distribution |
| 48700-025-065-075 | Outer Diameter 6.5 mm | In distribution |
| 48700-010-080-035 | Outer Diameter 8 mm | In distribution |
| 48700-010-065-075 | Outer Diameter 6.5 mm | In distribution |
| 48700-020-090-080 | Outer Diameter 9 mm | In distribution |
| 48700-030-075-035 | Angle 30 ° | In distribution |
| 48700-010-070-050 | Outer Diameter 7 mm | In distribution |
| 48700-030-095-100 | Angle 30 ° | In distribution |
| 48700-020-090-100 | Length 100 mm | In distribution |
| 48700-025-075-130 | Outer Diameter 7.5 mm | In distribution |
| 48700-010-080-090 | Outer Diameter 8 mm | In distribution |
| 48700-030-075-030 | Angle 30 ° | In distribution |
| 48700-020-080-030 | Length 30 mm | In distribution |
| 48700-020-080-065 | Outer Diameter 8 mm | In distribution |
| 48700-030-105-075 | Length 75 mm | In distribution |
| 48700-010-105-075 | Outer Diameter 10.5 mm | In distribution |
| 48700-025-075-040 | Outer Diameter 7.5 mm | In distribution |
| 48700-015-085-120 | Outer Diameter 8.5 mm | In distribution |
| 48017-55-200 | Length 200 mm | In distribution |
| 48700-010-070-095 | Outer Diameter 7 mm | In distribution |
| 48700-020-075-070 | Outer Diameter 7.5 mm | In distribution |
| 48700-010-090-045 | Outer Diameter 9 mm | In distribution |
| 48700-030-075-090 | Outer Diameter 7.5 mm | In distribution |
| 48700-010-065-025 | Outer Diameter 6.5 mm | In distribution |
| 48700-025-100-115 | Outer Diameter 10 mm | In distribution |
| 48700-030-070-050 | Angle 30 ° | In distribution |
| 48027-55-040 | Length 40 mm | In distribution |
| 48700-010-070-125 | Outer Diameter 7 mm | In distribution |
| 48700-020-065-040 | Outer Diameter 6.5 mm | In distribution |
| 48700-015-105-125 | Outer Diameter 10.5 mm | In distribution |
| 48700-020-085-050 | Outer Diameter 8.5 mm | In distribution |
| 48700-010-065-065 | Outer Diameter 6.5 mm | In distribution |
Showing 250 of 258 catalogue numbers.
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 |
| Polaris 4.75 TI Spinal System | Biomet Spine | 256 |
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.