Response 4.5/5.0 Spine System
4.5/5.0 Reduction Polyaxial Pedicle Screw DL 5.5MM X 22.5MM
15manufacturers in China registered for this device type
109catalogue numbers in this listing
5510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Shandong (3). 6 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 15. All 15 manufacturers in China registered for Thoracolumbosacral Pedicle Screw System
Record
| Listed by | Orthopediatrics, Corp, United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K181390 |
| Record published | 2020-03-05 |
| Record revised | 2025-07-02 (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, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00-1600-3262 | In distribution | |
| 01-1600-0027 | In distribution | |
| 00-1600-2745 | In distribution | |
| 00-1600-2622 | In distribution | |
| 00-1600-7550 | In distribution | |
| 00-1600-9530 | In distribution | |
| 00-1600-9522 | In distribution | |
| 00-1600-2727 | In distribution | |
| 00-1600-3520 | In distribution | |
| 00-1600-2675 | In distribution | |
| 00-1600-3325 | In distribution | |
| 00-1600-5062 | In distribution | |
| 00-1600-4555 | In distribution | |
| 00-1600-3780 | In distribution | |
| 00-1600-3627 | In distribution | |
| 00-1600-7640 | In distribution | |
| 00-1600-3622 | In distribution | |
| 00-1600-3422 | In distribution | |
| 00-1600-9620 | In distribution | |
| 00-1600-6820 | In distribution | |
| 00-1600-5066 | In distribution | |
| 00-1600-3435 | In distribution | |
| 00-1600-3251 | In distribution | |
| 00-1600-3253 | In distribution | |
| 00-1600-7020 | In distribution | |
| 00-1600-7422 | In distribution | |
| 00-1600-3725 | In distribution | |
| 00-1600-3635 | In distribution | |
| 00-1600-9645 | In distribution | |
| 00-1600-2427 | In distribution | |
| 00-1600-3720 | In distribution | |
| 00-1600-2655 | In distribution | |
| 00-1600-9630 | In distribution | |
| 00-1600-3640 | In distribution | |
| 00-1600-3625 | In distribution | |
| 00-1600-7650 | In distribution | |
| 00-1600-5030 | In distribution | |
| 00-1600-2625 | In distribution | |
| 00-1600-3620 | In distribution | |
| 00-1600-7435 | In distribution | |
| 01-1600-0300 | In distribution | |
| 00-1600-2760 | In distribution | |
| 00-1600-7545 | In distribution | |
| 00-1600-5018 | In distribution | |
| 00-1600-7555 | In distribution | |
| 01-1600-9250 | In distribution | |
| 00-1600-3252 | In distribution | |
| 00-1600-7630 | In distribution | |
| 00-1600-3335 | In distribution | |
| 01-1600-6035 | In distribution | |
| 00-1600-3630 | In distribution | |
| 00-1600-3645 | In distribution | |
| 00-1600-3149 | In distribution | |
| 00-1600-2530 | In distribution | |
| 00-1600-3265 | In distribution | |
| 00-1600-3430 | In distribution | |
| 00-1600-5051 | In distribution | |
| 00-1600-7427 | In distribution | |
| 00-1600-3259 | In distribution | |
| 00-1600-9665 | In distribution | |
| 00-1600-3043 | In distribution | |
| 00-1600-7527 | In distribution | |
| 00-1600-3322 | In distribution | |
| 00-1600-5016 | In distribution | |
| 00-1600-4001 | In distribution | |
| 00-1600-3333 | In distribution | |
| 00-1600-3250 | In distribution | |
| 00-1600-7050 | In distribution | |
| 00-1600-6900 | In distribution | |
| 00-1600-7430 | In distribution | |
| 00-1600-2770 | In distribution | |
| 00-1600-9420 | In distribution | |
| 00-1600-3266 | In distribution | |
| 00-1600-2775 | In distribution | |
| 00-1600-7635 | In distribution | |
| 00-1600-7675 | In distribution | |
| 00-1600-3047 | In distribution | |
| 00-1600-2440 | In distribution | |
| 00-1600-7670 | In distribution | |
| 00-1600-7645 | In distribution | |
| 00-1600-9545 | In distribution | |
| 00-1600-9660 | In distribution | |
| 00-1600-7425 | In distribution | |
| 00-1600-9680 | In distribution | |
| 00-1600-3440 | In distribution | |
| 00-1600-3535 | In distribution | |
| 00-1600-7680 | In distribution | |
| 01-1600-5000 | In distribution | |
| 00-1600-3313 | In distribution | |
| 00-1600-5036 | In distribution | |
| 00-1600-2545 | In distribution | |
| 00-1600-5052 | In distribution | |
| 00-1600-3735 | In distribution | |
| 00-1600-7030 | In distribution | |
| 00-1600-3680 | In distribution | |
| 00-1600-5026 | In distribution | |
| 00-1600-7525 | In distribution | |
| 00-1600-3305 | In distribution | |
| 00-1600-3530 | In distribution | |
| 00-1600-3670 | In distribution | |
| 01-1600-6140 | In distribution | |
| 00-1600-2750 | In distribution | |
| 00-1600-3525 | In distribution | |
| 00-1600-2527 | In distribution | |
| 00-1600-9425 | In distribution | |
| 01-1600-6036 | In distribution | |
| 00-1600-7627 | In distribution | |
| 00-1600-9635 | In distribution | |
| 00-1600-2730 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| The Jasper Spinal Fixation System | Gbs Commonwealth Co., Ltd. | 32,491 |
| Invictus | Alphatec Spine, Inc. | 4,722 |
| Vital Spinal Fixation System | Highridge Medical, LLC | 4,422 |
| Innoverse Spinal System | CG MedTech Co., Ltd. | 4,240 |
| 4CIS® Chiron Spinal Fixation System | Alpha AI Co., Ltd. | 3,787 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 3,522 |
| Hedjet System | Medyssey Co., Ltd. | 3,438 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 3,424 |
| Mega Plus MIS Spine System | BK Meditech Co., Ltd. | 3,396 |
| ReLine | Nuvasive, Inc. | 2,882 |
| Nex-D2 | Next Orthosurgical | 2,765 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2,386 |
Showing 12 of 1,490. All products under Thoracolumbosacral Pedicle Screw System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K222105 | 2023-03-23 |
| K193100 | 2020-03-24 |
| K181390 | 2018-09-18 |
| K160466 | 2016-03-23 |
| K150600 | 2015-05-22 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 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 | |
| 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.