Response 5.5/6.0 Spine System
5.5/6.0 Polyaxial Reduction Single Lead Pedicle Screw - DIA 8.0mm, 110mm Length
11manufacturers in China registered for this device type
373catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Orthopediatrics, Corp, United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K181390 |
| Record published | 2020-03-05 |
| Record revised | 2025-07-02 (version 6) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2023-10-17 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00-1350-6630 | In distribution | |
| 00-1300-2840 | In distribution | |
| 00-1350-9685 | In distribution | |
| 00-1650-8680 | In distribution | |
| 00-1350-6625 | In distribution | |
| 00-1650-1627 | In distribution | |
| 00-1350-2840 | In distribution | |
| 00-1650-6535 | In distribution | |
| 00-1350-1420 | In distribution | |
| 00-1650-1425 | In distribution | |
| 00-1300-3170 | In distribution | |
| 00-1350-3840 | In distribution | |
| 00-1350-2550 | In distribution | |
| 01-1003-6235 | In distribution | |
| 00-1350-0835 | In distribution | |
| 00-1650-0725 | In distribution | |
| 00-1650-1645 | In distribution | |
| 00-1350-3811 | In distribution | |
| 00-1650-1545 | In distribution | |
| 00-1350-3725 | In distribution | |
| 00-1650-0740 | In distribution | |
| 00-1350-3910 | In distribution | |
| 00-1350-2930 | In distribution | |
| 00-1300-8235 | In distribution | |
| 00-1650-8427 | In distribution | |
| 00-1350-2765 | In distribution | |
| 00-1350-6675 | In distribution | |
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| 00-1350-3635 | In distribution | |
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| 00-1350-1965 | In distribution | |
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| 00-1300-0965 | In distribution | |
| 00-1350-0570 | In distribution | |
| 00-1350-1775 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,188 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Orthopediatrics, Corp | 510(k) number | 2020-07-06 | Class II | Under Investigation by firm | Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device | 73 units | |
| Orthopediatrics, Corp | 510(k) number | 2017-08-03 | Class II | Employee error | The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws. | 24 units | 2019-05-08 |
| Orthopediatrics, Corp | 510(k) number | 2015-11-10 | Class II | Process change control | Response Spine UniAxial Pedicle & UniAxial Reduction Pedicle Screws may have been manufactured incorrectly, thus preventing the driver from fully engaging into the hexagonal drive feature of the screw. | 102 | 2016-05-23 |
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.