Fenestrated Screws
Bottom Level, Janus Fenestrated Implant & Instrument Case
15manufacturers in China registered for this device type
115catalogue numbers in this listing
6recalls 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 | Orthofix US LLC, 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, Exporter |
| 510(k) | K180179 |
| Record published | 2019-03-12 |
| Record revised | 2026-02-20 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 36-4675 | In distribution | |
| 36-4975 | In distribution | |
| 36-4865 | In distribution | |
| 36-4860 | In distribution | |
| 36-6311 | In distribution | |
| 36-5645SP | In distribution | |
| 36-6333 | In distribution | |
| 36-4750 | In distribution | |
| 36-4470 | In distribution | |
| 36-6321 | In distribution | |
| 36-4560 | In distribution | |
| 36-4460 | In distribution | |
| 36-4475 | In distribution | |
| 36-5755SP | In distribution | |
| 36-5840SP | In distribution | |
| 36-5940SP | In distribution | |
| 36-5455SP | In distribution | |
| 36-4770 | In distribution | |
| 36-5955SP | In distribution | |
| 36-6320 | In distribution | |
| 36-4435 | In distribution | |
| 36-4745 | In distribution | |
| 36-4680 | In distribution | |
| 36-4575 | In distribution | |
| 36-6300 | In distribution | |
| 36-5640SP | In distribution | |
| 36-4660 | In distribution | |
| 36-6312 | In distribution | |
| 36-5430SP | In distribution | |
| 36-6310 | In distribution | |
| 36-4855 | In distribution | |
| 36-5445SP | In distribution | |
| 36-4570 | In distribution | |
| 36-4850 | In distribution | |
| 36-5730SP | In distribution | |
| 36-5530SP | In distribution | |
| 36-4645 | In distribution | |
| 36-5945SP | In distribution | |
| 36-4840 | In distribution | |
| 36-4835 | In distribution | |
| 36-4440 | In distribution | |
| 36-4980 | In distribution | |
| 36-4740 | In distribution | |
| 36-5635SP | In distribution | |
| 36-4935 | In distribution | |
| 36-4655 | In distribution | |
| 36-4845 | In distribution | |
| 36-5435SP | In distribution | |
| 36-4880 | In distribution | |
| 36-5655SP | In distribution | |
| 36-4965 | In distribution | |
| 36-6315 | In distribution | |
| 36-4875 | In distribution | |
| 36-5935SP | In distribution | |
| 36-4940 | In distribution | |
| 36-4640 | In distribution | |
| 36-4780 | In distribution | |
| 36-5855SP | In distribution | |
| 36-4445 | In distribution | |
| 36-4775 | In distribution | |
| 36-5745SP | In distribution | |
| 36-6322 | In distribution | |
| 36-4830 | In distribution | |
| 36-4540 | In distribution | |
| 36-4545 | In distribution | |
| 36-5835SP | In distribution | |
| 36-5535SP | In distribution | |
| 36-6316 | In distribution | |
| 36-4480 | In distribution | |
| 36-4930 | In distribution | |
| 36-5845SP | In distribution | |
| 36-5950SP | In distribution | |
| 36-4955 | In distribution | |
| 36-4945 | In distribution | |
| 36-5550SP | In distribution | |
| 36-5650SP | In distribution | |
| 36-4535 | In distribution | |
| 36-4735 | In distribution | |
| 36-4580 | In distribution | |
| 36-5555SP | In distribution | |
| 36-4765 | In distribution | |
| 36-4960 | In distribution | |
| 36-4755 | In distribution | |
| 36-5750SP | In distribution | |
| 36-6314 | In distribution | |
| 36-4450 | In distribution | |
| 36-4555 | In distribution | |
| 36-4550 | In distribution | |
| 36-6313 | In distribution | |
| 36-5830SP | In distribution | |
| 36-5850SP | In distribution | |
| 36-5930SP | In distribution | |
| 36-4730 | In distribution | |
| 36-4970 | In distribution | |
| 36-5545SP | In distribution | |
| 36-4650 | In distribution | |
| 36-4465 | In distribution | |
| 36-4870 | In distribution | |
| 36-4455 | In distribution | |
| 36-5540SP | In distribution | |
| 36-5735SP | In distribution | |
| 36-5450SP | In distribution | |
| 36-5630SP | In distribution | |
| 36-4565 | In distribution | |
| 36-4635 | In distribution | |
| 36-4670 | In distribution | |
| 36-6300B | In distribution | |
| 36-4430 | In distribution | |
| 36-4530 | In distribution | |
| 36-4630 | In distribution | |
| 36-5440SP | In distribution | |
| 36-4665 | In distribution | |
| 36-4950 | In distribution | |
| 36-4760 | In distribution | |
| 36-5740SP | 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
Recalls
3 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 |
|---|---|---|---|---|---|
| 2025-09-19 | Class II | Process change control | Polyaxial screws do not meet performance standards. | 624 units | |
| 2017-08-02 | Class II | Nonconforming Material/Component | The plastic core of the Decorticating Planer was found to be missing, which could result in scoring of the bone screw neck if used at or beyond a 23 degree angle. | 6 planers | 2018-05-04 |
| 2015-05-18 | Class II | Unknown/Undetermined by firm | The Firebird Spinal Fixation System 6.5 mm x 55 mm Bone Screw, Self-Tapping is currently mislabeled at the distal tip of the bone screw showing a length measurement of 50 mm instead of 55 mm. | 45 units | 2015-10-30 |
| 2011-04-01 | Not classified | Device Design | Upon reaching torque limit, there is a possibility the product may jam or exhibit a ratchet direction switch from forward to reverse. | 287 units | 2012-03-23 |
| 2010-10-22 | Not classified | Other | There is a possibility that certain Anti-Splay Caps may not mate properly during assembly of the construct to the Screw Body with Multi-Axial Reduction Screw Assemblies. | 166 Units | 2011-04-25 |
| 2010-10-22 | Not classified | Other | There is a possibility that certain Multi-Axial Screws have spherical heads measuring less than the allowable tolerance. | 27 (19 of 77-7630) (8 of 77-8630) | 2011-05-31 |
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.