Response 4.5/5.0 Spine System
4.5/5.0 Reduction Polyaxial Pedicle Screw DL 5.5MM X 27.5MM
11manufacturers in China registered for this device type
139catalogue 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 | 2025-04-10 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00-1600-9527 | In distribution | |
| 01-1600-9081 | In distribution | |
| 00-1600-2665 | In distribution | |
| 00-1600-3722 | In distribution | |
| 00-1600-5760 | In distribution | |
| 00-1600-5034 | In distribution | |
| 00-1600-5022 | In distribution | |
| 00-1600-3151 | In distribution | |
| 00-1600-5056 | In distribution | |
| 01-1600-6136 | In distribution | |
| 00-1600-7625 | In distribution | |
| 00-1600-3727 | In distribution | |
| 00-1600-3545 | In distribution | |
| 00-1600-2540 | In distribution | |
| 00-1600-5061 | In distribution | |
| 00-1600-9627 | In distribution | |
| 00-1600-2680 | In distribution | |
| 00-1600-5740 | In distribution | |
| 00-1600-3655 | In distribution | |
| 00-1600-9625 | In distribution | |
| 00-1600-2620 | In distribution | |
| 00-1600-3249 | In distribution | |
| 00-1600-2435 | In distribution | |
| 00-1600-4565 | In distribution | |
| 00-1600-7540 | In distribution | |
| 00-1600-2722 | In distribution | |
| 00-1600-5065 | In distribution | |
| 00-1600-3665 | In distribution | |
| 00-1600-3334 | In distribution | |
| 00-1600-3540 | In distribution | |
| 01-1600-0026 | In distribution | |
| 00-1600-7440 | In distribution | |
| 00-1600-2422 | In distribution | |
| 00-1600-5020 | In distribution | |
| 00-1600-3045 | In distribution | |
| 00-1600-2635 | In distribution | |
| 00-1600-9430 | In distribution | |
| 00-1600-3770 | In distribution | |
| 00-1600-3775 | In distribution | |
| 00-1600-9535 | In distribution | |
| 00-1600-3312 | In distribution | |
| 00-1600-9550 | In distribution | |
| 00-1600-9540 | In distribution | |
| 00-1600-3765 | In distribution | |
| 00-1600-2630 | In distribution | |
| 00-1600-9670 | In distribution | |
| 00-1600-5014 | In distribution | |
| 00-1600-2735 | In distribution | |
| 00-1600-2780 | In distribution | |
| 00-1600-9440 | In distribution | |
| 00-1600-2660 | In distribution | |
| 00-1600-4561 | In distribution | |
| 00-1600-7522 | In distribution | |
| 00-1600-5780 | In distribution | |
| 00-1600-3740 | In distribution | |
| 00-1600-9445 | In distribution | |
| 00-1600-7620 | In distribution | |
| 00-1600-2550 | In distribution | |
| 00-1600-7655 | In distribution | |
| 00-1600-2650 | In distribution | |
| 00-1600-2645 | In distribution | |
| 00-1600-5024 | In distribution | |
| 00-1600-3314 | In distribution | |
| 00-1600-2520 | In distribution | |
| 00-1600-3420 | In distribution | |
| 00-1600-2720 | In distribution | |
| 00-1600-2740 | In distribution | |
| 00-1600-2535 | In distribution | |
| 00-1600-3522 | In distribution | |
| 00-1600-3260 | In distribution | |
| 00-1600-7080 | In distribution | |
| 00-1600-9622 | In distribution | |
| 00-1600-7622 | In distribution | |
| 00-1600-2430 | In distribution | |
| 00-1600-3150 | In distribution | |
| 01-1600-6135 | In distribution | |
| 00-1600-2525 | In distribution | |
| 00-1600-2420 | In distribution | |
| 00-1600-9655 | In distribution | |
| 00-1600-5028 | In distribution | |
| 00-1600-3323 | In distribution | |
| 00-1600-3550 | In distribution | |
| 00-1600-3730 | In distribution | |
| 00-1600-3152 | In distribution | |
| 00-1600-9520 | In distribution | |
| 00-1600-3264 | In distribution | |
| 00-1600-2725 | In distribution | |
| 00-1600-5032 | In distribution | |
| 00-1600-2522 | In distribution | |
| 00-1600-7520 | In distribution | |
| 00-1600-3332 | In distribution | |
| 01-1600-6236 | In distribution | |
| 00-1600-2670 | In distribution | |
| 00-1600-3660 | In distribution | |
| 00-1600-3425 | In distribution | |
| 00-1600-7530 | In distribution | |
| 00-1600-5055 | In distribution | |
| 00-1600-3256 | In distribution | |
| 00-1600-3041 | In distribution | |
| 00-1600-7535 | In distribution | |
| 00-1600-3427 | In distribution | |
| 00-1600-2627 | In distribution | |
| 00-1600-3760 | In distribution | |
| 00-1600-9555 | In distribution | |
| 00-1600-3750 | In distribution | |
| 00-1600-3650 | In distribution | |
| 00-1600-3263 | In distribution | |
| 00-1600-3304 | In distribution | |
| 00-1600-9435 | In distribution | |
| 00-1600-9675 | In distribution | |
| 00-1600-7445 | In distribution | |
| 00-1600-9525 | In distribution | |
| 00-1600-9422 | In distribution | |
| 00-1600-3303 | In distribution | |
| 00-1600-2755 | In distribution | |
| 00-1600-3254 | In distribution | |
| 00-1600-9650 | In distribution | |
| 00-1600-3675 | In distribution | |
| 00-1600-2765 | In distribution | |
| 00-1600-3324 | In distribution | |
| 00-1600-7660 | In distribution | |
| 00-1600-7060 | In distribution | |
| 00-1600-3527 | In distribution | |
| 00-1600-3302 | In distribution | |
| 00-1600-3315 | In distribution | |
| 00-1600-3755 | In distribution | |
| 00-1600-3261 | In distribution | |
| 00-1600-7040 | In distribution | |
| 00-1600-3745 | In distribution | |
| 00-1600-3255 | In distribution | |
| 00-1600-7665 | In distribution | |
| 00-1600-9640 | In distribution | |
| 00-1600-7420 | In distribution | |
| 00-1600-2640 | In distribution | |
| 00-1600-9427 | In distribution | |
| 00-1600-7070 | In distribution | |
| 00-1600-2425 | In distribution | |
| 00-1600-4551 | In distribution | |
| 01-1600-6235 | In distribution |
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
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.