Response Spine 5.5/6.0 System
5.5/6.0 Polyaxial Reduction Pedicle Screws - Ø6.5mm, 85mm Length
13manufacturers in China registered for this device type
78catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (2), Shandong (2). 4 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 |
| 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 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Changzhou Yonghua Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
Showing 12 of 13. All 13 manufacturers in China registered for Orthosis, Spinal Pedicle Fixation
Record
| Listed by | Orthopediatrics, Corp, United States |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K150600 |
| Record published | 2016-10-14 |
| Record revised | 2025-04-11 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00-1300-9685 | In distribution | |
| 00-1300-9670 | In distribution | |
| 00-1300-2090 | In distribution | |
| 00-1300-1775 | In distribution | |
| 00-1300-0775 | In distribution | |
| 00-1300-6635 | In distribution | |
| 00-1300-9570 | In distribution | |
| 00-1300-2740 | In distribution | |
| 00-1300-1650 | In distribution | |
| 00-1300-8635 | In distribution | |
| 00-1300-8540 | In distribution | |
| 00-1300-0565 | In distribution | |
| 00-1300-1635 | In distribution | |
| 00-1300-3055 | In distribution | |
| 00-1300-7560 | In distribution | |
| 00-1300-2812 | In distribution | |
| 00-1300-6560 | In distribution | |
| 00-1300-7565 | In distribution | |
| 00-1300-2745 | In distribution | |
| 00-1300-0625 | In distribution | |
| 00-1300-1430 | In distribution | |
| 00-1300-9545 | In distribution | |
| 00-1300-7520 | In distribution | |
| 00-1300-8525 | In distribution | |
| 00-1300-7645 | In distribution | |
| 00-1300-2055 | In distribution | |
| 00-1300-9520 | In distribution | |
| 00-1300-8425 | In distribution | |
| 00-1300-2640 | In distribution | |
| 00-1300-3011 | In distribution | |
| 00-1300-1765 | In distribution | |
| 00-1003-4001 | In distribution | |
| 00-1300-1740 | In distribution | |
| 00-1300-2430 | In distribution | |
| 00-1300-6665 | In distribution | |
| 00-1300-0765 | In distribution | |
| 00-1300-8675 | In distribution | |
| 00-1300-0675 | In distribution | |
| 00-1300-0750 | In distribution | |
| 00-1300-1755 | In distribution | |
| 00-1300-3080 | In distribution | |
| 00-1300-2811 | In distribution | |
| 00-1300-2425 | In distribution | |
| 00-1300-1525 | In distribution | |
| 00-1300-2060 | In distribution | |
| 00-1300-6650 | In distribution | |
| 00-1300-2570 | In distribution | |
| 00-1300-1645 | In distribution | |
| 00-1300-2050 | In distribution | |
| 00-1300-0680 | In distribution | |
| 00-1300-6630 | In distribution | |
| 00-1300-0440 | In distribution | |
| 00-1300-6545 | In distribution | |
| 00-1300-2970 | In distribution | |
| 00-1300-2010 | In distribution | |
| 00-1300-8435 | In distribution | |
| 00-1300-1640 | In distribution | |
| 00-1300-1570 | In distribution | |
| 00-1300-2650 | In distribution | |
| 00-1300-2535 | In distribution | |
| 00-1300-9655 | In distribution | |
| 00-1300-1745 | In distribution | |
| 00-1300-1560 | In distribution | |
| 00-1300-7650 | In distribution | |
| 00-1300-8645 | In distribution | |
| 00-1300-7620 | In distribution | |
| 00-1300-9425 | In distribution | |
| 00-1300-8680 | In distribution | |
| 00-1300-8420 | In distribution | |
| 00-1300-7545 | In distribution | |
| 00-1300-2780 | In distribution | |
| 00-1300-2555 | In distribution | |
| 00-1300-1665 | In distribution | |
| 00-1300-9535 | In distribution | |
| 00-1300-2645 | In distribution | |
| 00-1300-2620 | In distribution | |
| 00-1300-2545 | In distribution | |
| 00-1300-2011 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,342 |
| Creo | Globus Medical, Inc. | 1,784 |
| ReLine | Nuvasive, Inc. | 1,718 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 1,525 |
| Apex Spine System | Spinecraft LLC | 1,114 |
| Revere | Globus Medical, Inc. | 1,051 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 974 |
| LnK Basic Spinal Fixation System | L&K Biomed Co., Ltd. | 935 |
| Arsenal | Alphatec Spine, Inc. | 932 |
| Zavation | Zavation | 864 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 809 |
| Apex-DL Spine System | Spinecraft LLC | 792 |
Showing 12 of 950. All products under Orthosis, Spinal Pedicle Fixation
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.