Response Spine 5.5/6.0 System
5.5/6.0 Polyaxial Reduction Pedicle Screws - Ø5.5mm, 55mm Length
13manufacturers in China registered for this device type
68catalogue 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, Spondylolisthesis Spinal Fixation
Record
| Listed by | Orthopediatrics, Corp, United States |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal 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 |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00-1300-6535 | In distribution | |
| 00-1300-6525 | In distribution | |
| 00-1300-8560 | In distribution | |
| 00-1300-0535 | In distribution | |
| 00-1300-6420 | In distribution | |
| 00-1300-7575 | In distribution | |
| 00-1300-8575 | In distribution | |
| 00-1300-0530 | In distribution | |
| 00-1300-2550 | In distribution | |
| 00-1300-2910 | In distribution | |
| 00-1300-2980 | In distribution | |
| 00-1300-2720 | In distribution | |
| 00-1300-9555 | In distribution | |
| 00-1300-0710 | In distribution | |
| 00-1300-2890 | In distribution | |
| 00-1300-1770 | In distribution | |
| 00-1300-2625 | In distribution | |
| 00-1300-2675 | In distribution | |
| 00-1300-9560 | In distribution | |
| 00-1300-0550 | In distribution | |
| 00-1300-7685 | In distribution | |
| 00-1300-8670 | In distribution | |
| 00-1300-0730 | In distribution | |
| 00-1300-7670 | In distribution | |
| 00-1300-6645 | In distribution | |
| 00-1300-0560 | In distribution | |
| 00-1300-8555 | In distribution | |
| 00-1300-1760 | In distribution | |
| 00-1300-2755 | In distribution | |
| 00-1300-6575 | In distribution | |
| 00-1003-6001 | In distribution | |
| 00-1300-9675 | In distribution | |
| 00-1300-1420 | In distribution | |
| 00-1300-2765 | In distribution | |
| 00-1300-6620 | In distribution | |
| 00-1300-8530 | In distribution | |
| 00-1300-3150 | In distribution | |
| 00-1300-9550 | In distribution | |
| 00-1300-0545 | In distribution | |
| 00-1300-7660 | In distribution | |
| 00-1300-9640 | In distribution | |
| 00-1300-8570 | In distribution | |
| 00-1300-1630 | In distribution | |
| 00-1300-3060 | In distribution | |
| 00-1300-2012 | In distribution | |
| 00-1300-6670 | In distribution | |
| 00-1300-1440 | In distribution | |
| 00-1300-6675 | In distribution | |
| 00-1300-2760 | In distribution | |
| 00-1300-2775 | In distribution | |
| 00-1300-8620 | In distribution | |
| 00-1300-3010 | In distribution | |
| 00-1300-2525 | In distribution | |
| 00-1300-9680 | In distribution | |
| 00-1300-2065 | In distribution | |
| 00-1300-0720 | In distribution | |
| 00-1300-2635 | In distribution | |
| 00-1300-1675 | In distribution | |
| 00-1300-1720 | In distribution | |
| 00-1300-2630 | In distribution | |
| 00-1300-2440 | In distribution | |
| 00-1300-0745 | In distribution | |
| 00-1300-9435 | In distribution | |
| 00-1300-3047 | In distribution | |
| 00-1300-0655 | In distribution | |
| 00-1300-2990 | In distribution | |
| 00-1300-1625 | In distribution | |
| 00-1300-4570 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,144 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 2,177 |
| ReLine | Nuvasive, Inc. | 2,010 |
| Creo | Globus Medical, Inc. | 1,619 |
| Perfix™ Spinal System | CG MedTech Co., Ltd. | 1,476 |
| Apex Spine System | Spinecraft LLC | 1,193 |
| Olympic | Astura Medical | 1,173 |
| Arsenal | Alphatec Spine, Inc. | 1,001 |
| Revere | Globus Medical, Inc. | 997 |
| Astra Spine System | Spinecraft LLC | 798 |
| Apex-DL Spine System | Spinecraft LLC | 735 |
| Zenius Spinal System | Medyssey Co., Ltd. | 712 |
Showing 12 of 811. All products under Orthosis, Spondylolisthesis Spinal 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.