Implanet Spine System
Dual Pedicular Hook, Short Blade
7manufacturers in China registered for this device type
386catalogue 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 | Implanet, France |
|---|---|
| FDA product code | OSH |
| Device type | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Manufacturer |
| 510(k) | K143731 |
| Record published | 2015-09-18 |
| Record revised | 2025-07-02 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Length 30 to 600 mm; outer diameter 3.5 to 8 mm; lumen/inner diameter 3.5 to 6 mm; circumference 4.5 to 6 mm; length 40 Nanometer; length 160 µm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Prebent Union Rod | Length 50 mm | In distribution |
| Dual Monoaxial Screw | Length 35 mm | In distribution |
| Monoaxial Pedicle Screw | diameter 8 mm length 55 mm | In distribution |
| Monoaxial Pedicle Screw | diameter 5 mm length 40 mm | In distribution |
| Straight Union Rod | Length 70 mm | In distribution |
| Polyaxial Pedicle Screw | diameter 6 mm length 45 mm | In distribution |
| Straight Union Rod CoCr | Length 80 mm | In distribution |
| Straight Union Rod CoCr | Length 600 mm | In distribution |
| Sub S1 Connector Screw | Length 80 mm | In distribution |
| Polyaxial Pedicle Screw | diameter 7.5 mm length 50 mm | In distribution |
| Prebent Union Rod | Length 90 mm | In distribution |
| Straight Union Rod | Length 300 mm | In distribution |
| Laminar hook → right offset | In distribution | |
| Straight Union Rod CoCr | Length 40 mm | In distribution |
| Dual Polyaxial Screw | Length 50 mm | In distribution |
| Polyaxial Pedicle Screw | diameter 7 mm length 45 mm | In distribution |
| Straight Union Rod | Length 400 mm | In distribution |
| Straight Union Rod CoCr | Length 400 mm | In distribution |
| Pedicle screw blocker | In distribution | |
| Dual Laminar Hook | In distribution | |
| Straight Union Rod CoCr | Length 40 mm | In distribution |
| Straight Union Rod | Length 600 mm | In distribution |
| Sub S1 Connector Screw | Length 55 mm | In distribution |
| Straight Union Rod CoCr | Length 90 mm | In distribution |
| Dual Monoaxial Screw | Length 35 mm | In distribution |
| Sub S1 Connector | In distribution | |
| Dual Polyaxial Screw | Length 60 mm | In distribution |
| Offset Rod to Rod Connector | Lumen/Inner Diameter 5.5 mm | In distribution |
| Straight Union Rod CoCr | Length 90 mm | In distribution |
| Dual Monoaxial Screw | Outer Diameter 5 mm | In distribution |
| Straight Union Rod | Length 40 mm | In distribution |
| Transverse Connector | length 56/69 mm | In distribution |
| Straight Union Rod | Length 200 mm | In distribution |
| Monoaxial Pedicle Screw | diameter 7 mm length 60 mm | In distribution |
| Straight Union Rod | Length 30 mm | In distribution |
| Sub S1 Connector Screw | Length 65 mm | In distribution |
| Straight Union Rod | Length 60 mm | In distribution |
| Straight Union Rod | Length 160 mm | In distribution |
| Dual Monoaxial Screw | Length 40 mm | In distribution |
| Straight Union Rod CoCr | Length 500 mm | In distribution |
| Straight Union Rod | Length 500 mm | In distribution |
| Offset Rod to Rod Connector | Lumen/Inner Diameter 3.5 mm | In distribution |
| Straight Union Rod | Length 30 mm | In distribution |
| Straight Union Rod | Length 400 mm | In distribution |
| Straight Rod CoCr | Length 120 mm | In distribution |
| Straight Union Rod CoCr | Length 80 mm | In distribution |
| Straight Union Rod | Outer Diameter 4 mm | In distribution |
| Prebent Union Rod | Length 100 mm | In distribution |
| Straight Union Rod | Length 100 mm | In distribution |
| Sub S1 Connector Screw | Length 75 mm | In distribution |
| Straight Union Rod | Length 100 mm | In distribution |
| Polyaxial Pedicle Screw | diameter 7 mm length 60 mm | In distribution |
| Straight Union Rod | Length 300 mm | In distribution |
| Dual Polyaxial Screw | Length 35 mm | In distribution |
| Dual Polyaxial Screw | Length 40 mm | In distribution |
| Straight Union Rod | Length 40 mm | In distribution |
| Dual Monoaxial Screw | Length 40 mm | In distribution |
| Pre-bent Union Rod | Length 60 mm | In distribution |
| Dual Polyaxial Screw | Length 45 mm | In distribution |
| Straight Rod CoCr | Length 400 mm | In distribution |
| Polyaxial Pedicle Screw | diameter 7.5 mm length 45 mm | In distribution |
| Straight Union Rod | Length 100 mm | In distribution |
| Prebent Union Rod | Length 100 mm | In distribution |
| Dual Polyaxial Screw | Length 60 mm | In distribution |
| Straight Union Rod | Length 90 mm | In distribution |
| Transverse Connector | length 36/39 mm | In distribution |
| Polyaxial Pedicle Screw | diameter 6 mm length 60 mm | In distribution |
| Monoaxial Pedicle Screw | diameter 5 mm lenght 35 mm | In distribution |
| Dual Monoaxial Screw | Length 60 mm | In distribution |
| Straight Union Rod CoCr | Length 300 mm | In distribution |
| Dual Monoaxial Screw | Length 45 mm | In distribution |
| Straight Union Rod | In distribution | |
| Dual Monoaxial Screw | Length 45 mm | In distribution |
| Straight Union Rod CoCr | Length 500 mm | In distribution |
| Straight Union Rod CoCr | Length 60 mm | In distribution |
| Polyaxial Pedicle Screw | diameter 7.5 mm length 55 mm | In distribution |
| Straight Union Rod CoCr | Length 70 mm | In distribution |
| Dual Monoaxial Screw | Length 60 mm | In distribution |
| Dual Monoaxial Screw | Length 55 mm | In distribution |
| Polyaxial Pedicle Screw | diameter 5.5 mm length 55 mm | In distribution |
| Dual Monoaxial Screw | Length 45 mm | In distribution |
| Pre-bent Union Rod | Length 100 mm | In distribution |
| Straight Union Rod CoCr | Length 60 mm | In distribution |
| Dual Monoaxial Screw | Length 35 mm | In distribution |
| Straight Union Rod CoCr | Length 100 mm | In distribution |
| Laminar hook → left offset | In distribution | |
| Straight Union Rod CoCr | Length 160 mm | In distribution |
| Dual Polyaxial Screw | Length 35 mm | In distribution |
| Sub S1 Connector Screw | Length 60 mm | In distribution |
| Straight Union Rod | Length 200 mm | In distribution |
| Dual Pedicular Hook, Short Blade | In distribution | |
| Straight Union Rod CoCr | Length 90 mm | In distribution |
| Straight Union Rod CoCr | Length 30 mm | In distribution |
| Straight Union Rod | Length 70 mm | In distribution |
| Prebent Union Rod | Length 70 mm | In distribution |
| Straight Union Rod | Length 400 mm | In distribution |
| Polyaxial Pedicle Screw | diameter 7 mm length 50 mm | In distribution |
| Prebent Union Rod | Length 90 mm | In distribution |
| Dual Polyaxial Screw | Length 55 mm | In distribution |
| Straight Union Rod | Length 200 mm | In distribution |
| Straight Union Rod CoCr | Length 80 mm | In distribution |
| Dual Polyaxial Screw | Length 55 mm | In distribution |
| Straight Rod CoCr | Length 300 mm | In distribution |
| Monoaxial Pedicle Screw | diameter 7 mm length 50 mm | In distribution |
| Straight Union Rod | Length 50 mm | In distribution |
| Prebent Union Rod | Length 40 mm | In distribution |
| Straight Union Rod | Length 600 mm | In distribution |
| Monoaxial Pedicle Screw | diameter 6 mm length 40 mm | In distribution |
| Straight Union Rod | Length 50 mm | In distribution |
| Dual Monoaxial Screw | Length 45 mm | In distribution |
| Dual Thoracic Hook | In distribution | |
| Prebent Union Rod | Length 80 mm | In distribution |
| Monoaxial Pedicle Screw | diameter 5 mm length 50 mm | In distribution |
| Sub S1 Connector Screw | Length 50 mm | In distribution |
| Dual Polyaxial Screw | Length 55 mm | In distribution |
| Dual Polyaxial Screw | Length 50 mm | In distribution |
| Straight Union Rod | Length 60 mm | In distribution |
| Prebent Union Rod | Length 80 mm | In distribution |
| Transverse Connector | length 68/81 mm | In distribution |
| Straight Union Rod CoCr | Length 30 mm | In distribution |
| Straight Union Rod CoCr | Length 80 mm | In distribution |
| Polyaxial Pedicle Screw | diameter 7.5 mm length 40 mm | In distribution |
| Straight Union Rod CoCr | Length 160 mm | In distribution |
| Pre-bent Union Rod | Length 80 mm | In distribution |
| Prebent Union Rod | Length 40 mm | In distribution |
| Straight Union Rod CoCr | Length 70 mm | In distribution |
| Straight Union Rod | Length 70 mm | In distribution |
| Prebent Union Rod | Length 40 mm | In distribution |
| Prebent Union Rod | Length 30 mm | In distribution |
| Straight Union Rod | Length 80 mm | In distribution |
| Axial Rod to Rod Connector | Outer Diameter 6.6 mm | In distribution |
| Dual Polyaxial Screw | Length 50 mm | In distribution |
| Straight Union Rod | Length 30 mm | In distribution |
| Straight Union Rod CoCr | Length 120 mm | In distribution |
| Straight Union Rod | Length 90 mm | In distribution |
| Straight Union Rod | Length 200 mm | In distribution |
| Dual Monoaxial Screw | Length 50 mm | In distribution |
| Straight Union Rod CoCr | Length 50 mm | In distribution |
| Polyaxial Pedicle Screw | diameter 7.5 mm length 60 mm | In distribution |
| Straight Union Rod CoCr | Length 100 mm | In distribution |
| Pedicular hook → short blade | In distribution | |
| Prebent Union Rod | Length 100 mm | In distribution |
| Prebent Union Rod | Length 40 mm | In distribution |
| Polyaxial Pedicle Screw | diameter 6.5 mm length 45 mm | In distribution |
| Straight Union Rod | Length 40 mm | In distribution |
| Pre-bent Union Rod | Length 30 mm | In distribution |
| Prebent Union Rod | Length 30 mm | In distribution |
| Straight Union Rod | Length 90 mm | In distribution |
| Straight Union Rod | Length 90 mm | In distribution |
| Prebent Union Rod | Length 100 mm | In distribution |
| Straight Union Rod CoCr | Length 110 mm | In distribution |
| Straight Union Rod CoCr | Length 50 mm | In distribution |
| Straight Union Rod CoCr | Length 60 mm | In distribution |
| Monoaxial Pedicle Screw | diameter 7mm length 55 mm | In distribution |
| Straight Union Rod | Length 500 mm | In distribution |
| Offset Rod to Rod Connector | Outer Diameter 5.5 mm | In distribution |
| Straight Union Rod CoCr | Length 400 mm | In distribution |
| Monoaxial Pedicle Screw | diameter 8 mm length 35 mm | In distribution |
| Monoaxial Pedicle Screw | diameter 8 mm length 50 mm | In distribution |
| Dual Polyaxial Screw | Length 55 mm | In distribution |
| Straight Union Rod | Length 40 mm | In distribution |
| Monoaxial Pedicle Screw | diameter 8mm length 40 mm | In distribution |
| Straight Union Rod CoCr | Length 30 mm | In distribution |
| Straight Union Rod | Length 40 mm | In distribution |
| Monoaxial Pedicle Screw | diameter 8mm length 60 mm | In distribution |
| Polyaxial Pedicle Screw | diameter 6.5 mm length 55 mm | In distribution |
| Straight Union Rod CoCr | Length 120 mm | In distribution |
| Straight Union Rod | Length 120 mm | In distribution |
| Straight Union Rod | Length 500 mm | In distribution |
| Straight Union Rod | Length 60 mm | In distribution |
| Dual Polyaxial Screw | Length 35 mm | In distribution |
| Straight Union Rod CoCr | Length 200 mm | In distribution |
| Straight Union Rod | Length 110 mm | In distribution |
| Prebent Union Rod | Length 70 mm | In distribution |
| Dual Thoracic Hook, Angled Left | In distribution | |
| Straight Union Rod | Length 120 mm | In distribution |
| Prebent Union Rod | Length 90 mm | In distribution |
| Polyaxial Pedicle Screw | diameter 7 mm length 55 mm | In distribution |
| Straight Union Rod | Length 120 mm | In distribution |
| Polyaxial Pedicle Screw | diameter 5 mm length 50 mm | In distribution |
| Straight Union Rod CoCr | Length 110 mm | In distribution |
| Straight Union Rod | Length 300 mm | In distribution |
| Straight Union Rod CoCr | Length 400 mm | In distribution |
| Straight Union Rod CoCr | Length 300 mm | In distribution |
| Prebent Union Rod | Length 60 mm | In distribution |
| Dual Monoaxial Screw | Length 50 mm | In distribution |
| Monoaxial Pedicle Screw | diameter 8mm length 45 mm | In distribution |
| Dual Polyaxial Screw | Length 50 mm | In distribution |
| Straight Union Rod | Length 50 mm | In distribution |
| Straight Union Rod CoCr | Length 90 mm | In distribution |
| Straight Union Rod CoCr | Length 200 mm | In distribution |
| Monoaxial Pedicle Screw | diameter 7 mm length 45 mm | In distribution |
| Prebent Union Rod | Length 90 mm | In distribution |
| Straight Union Rod | Outer Diameter 4.5 mm | In distribution |
| Monoaxial Pedicle Screw | diameter 6 mm length 60 mm | In distribution |
| Monoaxial Pedicle Screw | diameter 6 mm length 50 mm | In distribution |
| Sub S1 Connector | Outer Diameter 6 mm | In distribution |
| Dual Monoaxial Screw | Length 55 mm | In distribution |
| Pre-bent Union Rod | Length 90 mm | In distribution |
| Polyaxial Pedicle Screw | diameter 5 mm length 45 mm | In distribution |
| Straight Union Rod | Length 400 mm | In distribution |
| Dual Laminar Hook Offset Right | In distribution | |
| Straight Union Rod CoCr | Length 400 mm | In distribution |
| Prebent Union Rod | Length 90 mm | In distribution |
| Straight Union Rod CoCr | Length 300 mm | In distribution |
| Polyaxial Pedicle Screw | diameter 6.5 mm length 60 mm | In distribution |
| Straight Union Rod CoCr | Length 40 mm | In distribution |
| Straight Union Rod | Length 50 mm | In distribution |
| Straight Union Rod | Length 110 mm | In distribution |
| Transverse Connector | length 42/47 mm | In distribution |
| Dual Polyaxial Screw | Outer Diameter 6 mm | In distribution |
| Straight Union Rod | Length 200 mm | In distribution |
| Straight Union Rod | Length 40 mm | In distribution |
| Straight Union Rod CoCr | Length 300 mm | In distribution |
| Dual Polyaxial Screw | Length 60 mm | In distribution |
| Straight Union Rod CoCr | Length 110 mm | In distribution |
| Prebent Union Rod | Length 80 mm | In distribution |
| Dual Thoracic Hook, Angled Right | In distribution | |
| Straight Union Rod CoCr | Length 120 mm | In distribution |
| Monoaxial Pedicle Screw | diameter 6mm length 45 mm | In distribution |
| Straight Union Rod CoCr | Length 100 mm | In distribution |
| Straight Union Rod CoCr | Length 50 mm | In distribution |
| Straight Union Rod CoCr | Length 50 mm | In distribution |
| Straight Union Rod | Length 120 mm | In distribution |
| Thoracic hook | In distribution | |
| Straight Union Rod | Length 100 mm | In distribution |
| Straight Union Rod CoCr | Length 200 mm | In distribution |
| Dual Monoaxial Screw | Length 35 mm | In distribution |
| Straight Union Rod | Length 80 mm | In distribution |
| Straight Union Rod | Length 30 mm | In distribution |
| Monoaxial Pedicle Screw | diameter 6 mm length 35 mm | In distribution |
| Axial Rod to Rod Connector | Outer Diameter 5.5 mm | In distribution |
| Polyaxial Pedicle Screw | diameter 5.5 mm length 50 mm | In distribution |
| Polyaxial Pedicle Screw | diameter 5.5 mm length 40 mm | In distribution |
| Polyaxial Pedicle Screw | diameter 6.5 mm length 35 mm | In distribution |
| Straight Union Rod | Length 300 mm | In distribution |
| Dual Monoaxial Screw | Length 55 mm | In distribution |
| Polyaxial Pedicle Screw | diameter 6 mm length 55 mm | In distribution |
| Monoaxial Pedicle Screw | diameter 7 mm length 40 mm | In distribution |
| Dual Polyaxial Screw | Length 45 mm | In distribution |
| Straight Union Rod | Length 50 mm | In distribution |
| Straight Union Rod | Length 400 mm | In distribution |
| Straight Union Rod | Length 120 mm | In distribution |
| Prebent Union Rod | Length 80 mm | In distribution |
| Monoaxial Pedicle Screw | diameter 6 mm length 55 mm | In distribution |
| Dual Polyaxial Screw | Length 45 mm | In distribution |
| Straight Union Rod | Length 500 mm | In distribution |
| Straight Union Rod | Length 70 mm | In distribution |
| Dual Polyaxial Screw | Length 35 mm | In distribution |
| Prebent Union Rod | Length 50 mm | In distribution |
Showing 250 of 300 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 |
| Everest® Spinal System | VB Spine LLC | 299 |
| Arsenal Deformity Spinal Fixation System | Alphatec Spine, Inc. | 258 |
| 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.