Arsenal
EXTENDED BODY NARROW BLADE THORACIC SUPRALAMINAR HOOK, 10.5mm
7manufacturers in China registered for this device type
820catalogue 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) | K161363 |
| Record published | 2016-04-27 |
| Record revised | 2024-09-11 (version 9) |
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 | Length 15 to 600 mm; outer diameter 4 to 10.5 mm; angle 15 to 30 °; height 5.5 to 10.5 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 48700-005-095-065 | Length 65 mm | In distribution |
| 47420-095-120 | Outer Diameter 9.5 mm | In distribution |
| 47000-095-085 | Length 85 mm | In distribution |
| 48500-090-050 | In distribution | |
| 48601-019-075 | In distribution | |
| 48500-095-040 | In distribution | |
| 47210-050-065 | Outer Diameter 5 mm | In distribution |
| 47005-55-050 | Outer Diameter 5.5 mm | In distribution |
| 47000-100-090 | Outer Diameter 10 mm | In distribution |
| 47210-072-085 | Length 85 mm | In distribution |
| 47005-55-120 | Length 120 mm | In distribution |
| 48410-075-030 | Outer Diameter 7.5 mm | In distribution |
| 47210-075-120 | Length 120 mm | In distribution |
| 47210-040-025 | Length 25 mm | In distribution |
| 48100-065-075 | Outer Diameter 6.5 mm | In distribution |
| 47421-070-040 | Length 40 mm | In distribution |
| 48100-045-025 | Outer Diameter 4.5 mm | In distribution |
| 48200-065-090 | Length 90 mm | In distribution |
| 47005-55-040 | Length 40 mm | In distribution |
| 48100-070-130 | Outer Diameter 7 mm | In distribution |
| 48310-050-050 | Outer Diameter 5 mm | In distribution |
| 47210-105-130 | Outer Diameter 10.5 mm | In distribution |
| 47010-040-055 | Outer Diameter 4 mm | In distribution |
| 48300-055-055 | Length 55 mm | In distribution |
| 47400-100-055 | Outer Diameter 10 mm | In distribution |
| 47000-072-100 | Length 100 mm | In distribution |
| 48700-000-070-040 | Length 40 mm | In distribution |
| 48600-012-030-065 | Angle 30 ° | In distribution |
| 47420-050-050 | Length 50 mm | In distribution |
| 47010-095-120 | Outer Diameter 9.5 mm | In distribution |
| 48600-037-065 | Angle 30 ° | In distribution |
| 48900-080-130 | Length 130 mm | In distribution |
| 48100-070-110 | Outer Diameter 7 mm | In distribution |
| 48600-015-045 | In distribution | |
| 47500-045-015 | Length 15 mm | In distribution |
| 47420-055-040 | Length 40 mm | In distribution |
| 47003-55-070 | Outer Diameter 5.5 mm | In distribution |
| 47000-085-085 | Length 85 mm | In distribution |
| 47000-060-035 | Outer Diameter 6 mm | In distribution |
| 48800-095-090 | Outer Diameter 9.5 mm | In distribution |
| 47000-100-120 | Length 120 mm | In distribution |
| 48700-000-085-075 | Length 75 mm | In distribution |
| 47400-075-075 | Length 75 mm | In distribution |
| 47500-070-035 | Length 35 mm | In distribution |
| 47000-100-070 | Outer Diameter 10 mm | In distribution |
| 47420-100-045 | Length 45 mm | In distribution |
| 48500-075-035 | In distribution | |
| 48300-045-050 | Outer Diameter 4.5 mm | In distribution |
| 47000-100-065 | Outer Diameter 10 mm | In distribution |
| 47210-105-090 | Length 90 mm | In distribution |
| 47001-55-120 | Length 120 mm | In distribution |
| 47400-095-050 | Length 50 mm | In distribution |
| 47010-100-065 | Outer Diameter 10 mm | In distribution |
| 48800-100-035 | Outer Diameter 10 mm | In distribution |
| 47100-080-085 | Length 85 mm | In distribution |
| 47420-105-050 | Length 50 mm | In distribution |
| 47200-065-070 | Length 70 mm | In distribution |
| 47100-072-020 | Length 20 mm | In distribution |
| 47420-070-055 | Length 55 mm | In distribution |
| 48700-005-090-070 | Outer Diameter 9 mm | In distribution |
| 47210-085-070 | Length 70 mm | In distribution |
| 48600-007-085 | In distribution | |
| 47520-070-055 | Length 55 mm | In distribution |
| 48600-011-030-095 | Angle 30 ° | In distribution |
| 48600-025-085 | In distribution | |
| 47520-055-035 | Length 35 mm | In distribution |
| 48700-030-075-100 | In distribution | |
| 47210-080-100 | Length 100 mm | In distribution |
| 47100-050-050 | Length 50 mm | In distribution |
| 47400-075-065 | Length 65 mm | In distribution |
| 47000-080-075 | Outer Diameter 8 mm | In distribution |
| 48200-050-030 | Outer Diameter 5 mm | In distribution |
| 48600-005-075 | In distribution | |
| 48500-075-020 | In distribution | |
| 47420-095-080 | Length 80 mm | In distribution |
| 47000-090-060 | Outer Diameter 9 mm | In distribution |
| 47400-065-060 | Length 60 mm | In distribution |
| 47200-100-065 | Outer Diameter 10 mm | In distribution |
| 48700-005-105-115 | Length 115 mm | In distribution |
| 48900-095-085 | Outer Diameter 9.5 mm | In distribution |
| 47400-050-030 | Length 30 mm | In distribution |
| 47100-095-050 | Outer Diameter 9.5 mm | In distribution |
| 47010-085-095 | Outer Diameter 8.5 mm | In distribution |
| 48400-065-030 | In distribution | |
| 47100-045-045 | Outer Diameter 4.5 mm | In distribution |
| 47089-55-040 | Length 40 mm | In distribution |
| 48400-065-095 | In distribution | |
| 48500-090-035 | In distribution | |
| 47000-085-090 | Outer Diameter 8.5 mm | In distribution |
| 48200-045-020 | Length 20 mm | In distribution |
| 47520-050-025 | Outer Diameter 5 mm | In distribution |
| 48700-000-105-085 | Length 85 mm | In distribution |
| 47420-075-085 | Length 85 mm | In distribution |
| 48600-015-055 | In distribution | |
| 47420-105-105 | Length 105 mm | In distribution |
| 48900-085-050 | Length 50 mm | In distribution |
| 47000-090-075 | Length 75 mm | In distribution |
| 47200-105-055 | Outer Diameter 10.5 mm | In distribution |
| 47058-65-080 | Length 80 mm | In distribution |
| 47400-075-120 | Length 120 mm | In distribution |
| 47090-55-040 | Length 40 mm | In distribution |
| 48400-040-020 | In distribution | |
| 48600-025-055 | In distribution | |
| 48800-070-095 | Length 95 mm | In distribution |
| 47090-55-080 | Outer Diameter 5.5 mm | In distribution |
| 47000-080-035 | Length 35 mm | In distribution |
| 48800-090-050 | Length 50 mm | In distribution |
| 47400-070-120 | Length 120 mm | In distribution |
| 47400-085-085 | Length 85 mm | In distribution |
| 47200-105-065 | Outer Diameter 10.5 mm | In distribution |
| 47400-055-060 | Length 60 mm | In distribution |
| 47010-105-030 | Length 30 mm | In distribution |
| 47210-070-040 | Outer Diameter 7 mm | In distribution |
| 48200-070-050 | Outer Diameter 7 mm | In distribution |
| 47000-072-090 | Length 90 mm | In distribution |
| 47420-055-060 | Length 60 mm | In distribution |
| 48600-009-105 | In distribution | |
| 48700-005-090-110 | Length 110 mm | In distribution |
| 48700-005-065-030 | Length 30 mm | In distribution |
| 48600-020-105 | In distribution | |
| 47100-072-095 | Outer Diameter 7.2 mm | In distribution |
| 47000-080-115 | Outer Diameter 8 mm | In distribution |
| 47010-095-040 | Length 40 mm | In distribution |
| 48700-000-070-045 | Length 45 mm | In distribution |
| 47210-075-100 | Length 100 mm | In distribution |
| 48500-090-030 | In distribution | |
| 47100-085-100 | Length 100 mm | In distribution |
| 47000-055-035 | Length 35 mm | In distribution |
| 48900-080-075 | Outer Diameter 8 mm | In distribution |
| 48400-075-060 | In distribution | |
| 48800-070-070 | Outer Diameter 7 mm | In distribution |
| 47010-085-035 | Length 35 mm | In distribution |
| 48600-018-085 | In distribution | |
| 47421-050-055 | Outer Diameter 5 mm | In distribution |
| 48601-018-075 | In distribution | |
| 47210-080-105 | Length 105 mm | In distribution |
| 47421-070-110 | Length 110 mm | In distribution |
| 48700-005-070-030 | Outer Diameter 7 mm | In distribution |
| 47005-55-055 | Outer Diameter 5.5 mm | In distribution |
| 47100-085-050 | Length 50 mm | In distribution |
| 48600-009-085 | In distribution | |
| 48601-003-105 | In distribution | |
| 47410-065-070 | Outer Diameter 6.5 mm | In distribution |
| 47088-65-080 | Outer Diameter 6.35 mm | In distribution |
| 48700-000-085-110 | Length 110 mm | In distribution |
| 47100-050-035 | Length 35 mm | In distribution |
| 48601-003-095 | In distribution | |
| 47200-070-025 | Length 25 mm | In distribution |
| 47410-060-045 | Outer Diameter 6 mm | In distribution |
| 48900-055-030 | Length 30 mm | In distribution |
| 48007-55-600 | Length 600 mm | In distribution |
| 47421-065-045 | Outer Diameter 6.5 mm | In distribution |
| 47210-065-095 | Outer Diameter 6.5 mm | In distribution |
| 47400-080-100 | Length 100 mm | In distribution |
| 48700-005-085-095 | Length 95 mm | In distribution |
| 48700-000-105-070 | Outer Diameter 10.5 mm | In distribution |
| 47420-100-030 | Outer Diameter 10 mm | In distribution |
| 47200-050-050 | Length 50 mm | In distribution |
| 47018-55-635 | Outer Diameter 6.35 mm | In distribution |
| 47400-100-090 | Length 90 mm | In distribution |
| 47420-040-050 | Length 50 mm | In distribution |
| 48600-013-022-075 | Angle 22 ° | In distribution |
| 47200-075-090 | Length 90 mm | In distribution |
| 47420-085-045 | Length 45 mm | In distribution |
| 47420-075-115 | Length 115 mm | In distribution |
| 48700-000-100-095 | Length 95 mm | In distribution |
| 47010-050-025 | Length 25 mm | In distribution |
| 47410-045-055 | Outer Diameter 4.5 mm | In distribution |
| 47420-075-110 | Length 110 mm | In distribution |
| 47003-55-100 | Outer Diameter 5.5 mm | In distribution |
| 48800-100-050 | Outer Diameter 10 mm | In distribution |
| 47003-55-055 | Length 55 mm | In distribution |
| 47400-100-060 | Outer Diameter 10 mm | In distribution |
| 47520-065-025 | Length 25 mm | In distribution |
| 48900-055-020 | Length 20 mm | In distribution |
| 47010-070-020 | Length 20 mm | In distribution |
| 47010-080-030 | Length 30 mm | In distribution |
| 47410-070-090 | Length 90 mm | In distribution |
| 48800-075-080 | Outer Diameter 7.5 mm | In distribution |
| 48300-070-125 | Length 125 mm | In distribution |
| 48300-070-085 | Outer Diameter 7 mm | In distribution |
| 47200-040-035 | Outer Diameter 4 mm | In distribution |
| 47100-105-100 | Length 100 mm | In distribution |
| 47400-080-050 | Length 50 mm | In distribution |
| 47420-095-055 | Length 55 mm | In distribution |
| 48500-080-095 | In distribution | |
| 47400-085-050 | Length 50 mm | In distribution |
| 48310-040-030 | Length 30 mm | In distribution |
| 47100-085-075 | Outer Diameter 8.5 mm | In distribution |
| 48300-055-040 | Outer Diameter 5.5 mm | In distribution |
| 47210-080-120 | Length 120 mm | In distribution |
| 47100-040-020 | Length 20 mm | In distribution |
| 48700-000-065-065 | Outer Diameter 6.5 mm | In distribution |
| 47400-055-065 | Length 65 mm | In distribution |
| 47520-060-045 | Length 45 mm | In distribution |
| 48500-075-130 | In distribution | |
| 47210-095-040 | Length 40 mm | In distribution |
| 47421-045-045 | Outer Diameter 4.5 mm | In distribution |
| 47520-045-055 | Length 55 mm | In distribution |
| 48800-075-090 | Length 90 mm | In distribution |
| 48700-000-095-090 | Outer Diameter 9.5 mm | In distribution |
| 48900-085-055 | Length 55 mm | In distribution |
| 47100-075-090 | Length 90 mm | In distribution |
| 48500-070-090 | In distribution | |
| 47000-095-090 | Length 90 mm | In distribution |
| 47210-100-035 | Length 35 mm | In distribution |
| 48200-055-030 | Length 30 mm | In distribution |
| 47520-055-020 | Length 20 mm | In distribution |
| 47400-080-030 | Length 30 mm | In distribution |
| 47210-105-055 | Outer Diameter 10.5 mm | In distribution |
| 47000-040-035 | Length 35 mm | In distribution |
| 48700-005-065-060 | Outer Diameter 6.5 mm | In distribution |
| 48700-005-095-035 | Length 35 mm | In distribution |
| 48410-050-025 | Outer Diameter 5 mm | In distribution |
| 48400-060-020 | In distribution | |
| 47200-070-095 | Length 95 mm | In distribution |
| 47400-105-125 | In distribution | |
| 48700-005-075-090 | Length 90 mm | In distribution |
| 47420-080-040 | Length 40 mm | In distribution |
| 47000-090-095 | Outer Diameter 9 mm | In distribution |
| 47006-40 | Length 40 mm | In distribution |
| 48600-017-085 | In distribution | |
| 48700-005-080-070 | Length 70 mm | In distribution |
| 47400-095-120 | Length 120 mm | In distribution |
| 48700-005-105-055 | Length 55 mm | In distribution |
| 47210-090-120 | Outer Diameter 9 mm | In distribution |
| 47000-090-035 | Length 35 mm | In distribution |
| 47100-055-025 | Length 25 mm | In distribution |
| 47100-085-095 | Length 95 mm | In distribution |
| 47500-055-045 | Length 45 mm | In distribution |
| 47400-095-090 | Length 90 mm | In distribution |
| 47089-55-080 | Outer Diameter 5.5 mm | In distribution |
| 47520-060-020 | Length 20 mm | In distribution |
| 47210-105-035 | Outer Diameter 10.5 mm | In distribution |
| 47088-65-040 | Length 40 mm | In distribution |
| 47200-040-030 | Length 30 mm | In distribution |
| 47420-095-040 | Length 40 mm | In distribution |
| 47410-040-060 | Outer Diameter 4 mm | In distribution |
| 48600-016-085 | In distribution | |
| 47010-065-050 | Length 50 mm | In distribution |
| 48900-105-045 | Outer Diameter 10.5 mm | In distribution |
| 47088-55-060 | Outer Diameter 5.5 mm | In distribution |
| 48100-065-040 | Length 40 mm | In distribution |
| 48800-100-090 | Outer Diameter 10 mm | In distribution |
| 48600-013-015-105 | Angle 15 ° | In distribution |
| 47410-070-045 | Length 45 mm | In distribution |
| 47000-095-045 | Outer Diameter 9.5 mm | In distribution |
| 48001-55-200 | Outer Diameter 5.5 mm | In distribution |
| 48800-095-085 | Outer Diameter 9.5 mm | In distribution |
| 47210-065-070 | Length 70 mm | In distribution |
Showing 250 of 300 catalogue numbers.
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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.