OP Response Spine System
Reduction Polyaxial Screw 4.0MM X 40MM
11manufacturers in China registered for this device type
129catalogue 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) | K130655 |
| Record published | 2015-09-08 |
| Record revised | 2025-05-14 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00-1003-3091 | In distribution | |
| 00-1003-3255 | In distribution | |
| 00-1003-4425 | In distribution | |
| 00-1003-5107 | In distribution | |
| 00-1003-3301 | In distribution | |
| 00-1003-5177 | In distribution | |
| 00-1003-4353 | In distribution | |
| 00-1003-4429 | In distribution | |
| 00-1003-4173 | In distribution | |
| 00-1003-5179 | In distribution | |
| 00-1003-3066 | In distribution | |
| 00-1003-5138 | In distribution | |
| 00-1003-4428 | In distribution | |
| 00-1003-4221 | In distribution | |
| 00-1003-4253 | In distribution | |
| 00-1003-3004 | In distribution | |
| 00-1003-4393 | In distribution | |
| 00-1003-4067 | In distribution | |
| 00-1003-4219 | In distribution | |
| 00-1003-3258 | In distribution | |
| 00-1003-3099 | In distribution | |
| 00-1003-4359 | In distribution | |
| 00-1003-4528 | In distribution | |
| 00-1003-4272 | In distribution | |
| 00-1003-4431 | In distribution | |
| 00-1003-3152 | In distribution | |
| 00-1003-4143 | In distribution | |
| 00-1003-4389 | In distribution | |
| 00-1003-4140 | In distribution | |
| 00-1003-4387 | In distribution | |
| 00-1003-3102 | In distribution | |
| 00-1003-4487 | In distribution | |
| 00-1003-4358 | In distribution | |
| 00-1003-4176 | In distribution | |
| 00-1003-5100 | In distribution | |
| 00-1003-5106 | In distribution | |
| 00-1003-4135 | In distribution | |
| 00-1003-3001 | In distribution | |
| 00-1003-4472 | In distribution | |
| 00-1003-4355 | In distribution | |
| 00-1003-4139 | In distribution | |
| 00-1003-4529 | In distribution | |
| 00-1003-3201 | In distribution | |
| 00-1003-5175 | In distribution | |
| 00-1003-4357 | In distribution | |
| 00-1003-5136 | In distribution | |
| 00-1003-4217 | In distribution | |
| 00-1003-4523 | In distribution | |
| 00-1003-4174 | In distribution | |
| 00-1003-5101 | In distribution | |
| 00-1003-3150 | In distribution | |
| 00-1003-3151 | In distribution | |
| 00-1003-4256 | In distribution | |
| 00-1003-4136 | In distribution | |
| 00-1003-4259 | In distribution | |
| 00-1003-3096 | In distribution | |
| 00-1003-4105 | In distribution | |
| 00-1003-3050 | In distribution | |
| 00-1003-4530 | In distribution | |
| 00-1003-4276 | In distribution | |
| 00-1003-4490 | In distribution | |
| 00-1003-4235 | In distribution | |
| 00-1003-4509 | In distribution | |
| 00-1003-4171 | In distribution | |
| 00-1003-4070 | In distribution | |
| 00-1003-4351 | In distribution | |
| 00-1003-4274 | In distribution | |
| 00-1003-3094 | In distribution | |
| 00-1003-3087 | In distribution | |
| 00-1003-5139 | In distribution | |
| 00-1003-4532 | In distribution | |
| 00-1003-4318 | In distribution | |
| 00-1003-4423 | In distribution | |
| 00-1003-3054 | In distribution | |
| 00-1003-4101 | In distribution | |
| 00-1003-4474 | In distribution | |
| 00-1003-4218 | In distribution | |
| 00-1003-3300 | In distribution | |
| 00-1003-4390 | In distribution | |
| 00-1003-3250 | In distribution | |
| 00-1003-4252 | In distribution | |
| 00-1003-4234 | In distribution | |
| 00-1003-4473 | In distribution | |
| 00-1003-3041 | In distribution | |
| 00-1003-6003 | In distribution | |
| 00-1003-4505 | In distribution | |
| 00-1003-5141 | In distribution | |
| 00-1003-3012 | In distribution | |
| 00-1003-3090 | In distribution | |
| 00-1003-4242 | In distribution | |
| 00-1003-4320 | In distribution | |
| 00-1003-3303 | In distribution | |
| 00-1003-3266 | In distribution | |
| 00-1003-4260 | In distribution | |
| 00-1003-3089 | In distribution | |
| 00-1003-5140 | In distribution | |
| 00-1003-3200 | In distribution | |
| 00-1003-4270 | In distribution | |
| 00-1003-4254 | In distribution | |
| 00-1003-4392 | In distribution | |
| 00-1003-5068 | In distribution | |
| 00-1003-4526 | In distribution | |
| 00-1003-3086 | In distribution | |
| 00-1003-5173 | In distribution | |
| 00-1003-4354 | In distribution | |
| 00-1003-5181 | In distribution | |
| 00-1003-4275 | In distribution | |
| 00-1003-3268 | In distribution | |
| 00-1003-4391 | In distribution | |
| 00-1003-4531 | In distribution | |
| 00-1003-3065 | In distribution | |
| 00-1003-4271 | In distribution | |
| 00-1003-4495 | In distribution | |
| 00-1003-4141 | In distribution | |
| 00-1003-4488 | In distribution | |
| 00-1003-3055 | In distribution | |
| 00-1003-4179 | In distribution | |
| 00-1003-3260 | In distribution | |
| 00-1003-4258 | In distribution | |
| 00-1003-5104 | In distribution | |
| 00-1003-5070 | In distribution | |
| 00-1003-3249 | In distribution | |
| 00-1003-3204 | In distribution | |
| 00-1003-4107 | In distribution | |
| 00-1003-4493 | In distribution | |
| 00-1003-4103 | In distribution | |
| 00-1003-3043 | In distribution | |
| 00-1003-5142 | In distribution | |
| 00-1003-4319 | 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.