LineSider
5.5/6.0mm, Non-mod Reduction 7.1mm - Dual to Quad, Non-cannulated - 7.5mm x 40mm
11manufacturers in China registered for this device type
948catalogue numbers in this listing
2recalls on this code
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 | Highridge Medical, LLC, United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K203367 |
| Record published | 2025-10-03 |
| Record revised | 2026-03-23 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LS-N6SA7555 | In distribution | |
| LS-RD55B060 | In distribution | |
| LS-SC7G7550 | In distribution | |
| LS-SC7G5035 | In distribution | |
| 0 | In distribution | |
| LS-N6RE7540 | In distribution | |
| LS-SC7G9570 | In distribution | |
| 0 | In distribution | |
| LS-N6RG9550 | In distribution | |
| LS-N6SE6545 | In distribution | |
| LS-N6SR9520 | In distribution | |
| LS-N6SR9590 | In distribution | |
| LS-N6SA4545 | In distribution | |
| LS-N6SR8510 | In distribution | |
| LS-N6SA9555 | In distribution | |
| LS-RD55C040 | In distribution | |
| 0 | In distribution | |
| LS-AC5060G2 | In distribution | |
| LS-N6MG1555 | In distribution | |
| 0 | In distribution | |
| LS-N6SG5530 | In distribution | |
| LS-SC7L4525 | In distribution | |
| 0 | In distribution | |
| LS-RD55F055 | In distribution | |
| 0 | In distribution | |
| 0 | In distribution | |
| 0 | In distribution | |
| 0 | In distribution | |
| LS-N6RA4550 | In distribution | |
| LS-N6RG5035 | In distribution | |
| 0 | In distribution | |
| 0 | In distribution | |
| ASY-01129 | In distribution | |
| 0 | In distribution | |
| LS-N6RG6540 | In distribution | |
| LS-N6SA6540 | In distribution | |
| LS-N6RA5035 | In distribution | |
| LS-N6SA5045 | In distribution | |
| 0 | In distribution | |
| LS-N6SA7550 | In distribution | |
| LS-N6MA7560 | In distribution | |
| 0 | In distribution | |
| LS-N6RA4520 | In distribution | |
| LS-N6RA9540 | In distribution | |
| LS-SC7L5535 | In distribution | |
| LS-N6MG8530 | In distribution | |
| LS-N6SR8590 | In distribution | |
| LS-N6CR8500 | In distribution | |
| LS-N6SE4535 | In distribution | |
| LS-N6SG8560 | In distribution | |
| LS-N6RG7560 | In distribution | |
| LS-N6SR1500 | In distribution | |
| 0 | In distribution | |
| 0 | In distribution | |
| LS-SC7L6540 | In distribution | |
| 0 | In distribution | |
| LS-N6SE5045 | In distribution | |
| LS-N6MA8535 | In distribution | |
| 0 | In distribution | |
| 0 | In distribution | |
| 0 | In distribution | |
| 0 | In distribution | |
| LS-N6MA7555 | In distribution | |
| LS-RD55F095 | In distribution | |
| 0 | In distribution | |
| LS-N6SR8580 | In distribution | |
| LS-N6RG8540 | In distribution | |
| LS-N6SR7590 | In distribution | |
| 0 | In distribution | |
| 0 | In distribution | |
| 0 | In distribution | |
| LS-RD55C090 | In distribution | |
| LS-N6SA1560 | In distribution | |
| LS-RD55C060 | In distribution | |
| LS-AC6063A2 | In distribution | |
| 0 | In distribution | |
| LS-N6SG5555 | In distribution | |
| 0 | In distribution | |
| 0 | In distribution | |
| LS-SC7L7525 | In distribution | |
| 0 | In distribution | |
| LS-IC55T35 | In distribution | |
| 0 | In distribution | |
| LS-SC7L5045 | In distribution | |
| 0 | In distribution | |
| LS-SC7L4550 | In distribution | |
| LS-RD55F065 | In distribution | |
| LS-N6MG8550 | In distribution | |
| 0 | In distribution | |
| LS-N6MG8555 | In distribution | |
| LS-N6SE5550 | In distribution | |
| LS-RD50E030 | In distribution | |
| LS-RD55F110 | In distribution | |
| 0 | In distribution | |
| LS-N6SA7540 | In distribution | |
| LS-N6ME7560 | In distribution | |
| LS-N6MG5035 | In distribution | |
| LS-RD55D080 | In distribution | |
| 0 | In distribution | |
| LS-N6SG7530 | In distribution | |
| LS-AC6060A1 | In distribution | |
| LS-N6MG5550 | In distribution | |
| LS-N6RG6530 | In distribution | |
| LS-SC7G7590 | In distribution | |
| LS-N6MA5025 | In distribution | |
| LS-RD55B120 | In distribution | |
| LS-N6RA6560 | In distribution | |
| LS-SC7E7525 | In distribution | |
| LS-SC7L5030 | In distribution | |
| 0 | In distribution | |
| LS-N6SA5060 | In distribution | |
| 0 | In distribution | |
| LS-N6RE6545 | In distribution | |
| LS-N6RG6545 | In distribution | |
| 0 | In distribution | |
| LS-N6SA5050 | In distribution | |
| LS-N6SG4535 | In distribution | |
| 0 | In distribution | |
| LS-N6SG4530 | In distribution | |
| LS-N6SA5525 | In distribution | |
| LS-N6SR9510 | In distribution | |
| LS-SC7L5035 | In distribution | |
| LS-SC7L5540 | In distribution | |
| LS-N6RA4555 | In distribution | |
| 0 | In distribution | |
| LS-N6SA4550 | In distribution | |
| LS-N6RG4545 | In distribution | |
| 0 | In distribution | |
| 0 | In distribution | |
| 0 | In distribution | |
| LS-N6RG5525 | In distribution | |
| LS-AC6063G2 | In distribution | |
| LS-N6SE6535 | In distribution | |
| 0 | In distribution | |
| LS-N6SR1570 | In distribution | |
| LS-N6RE7555 | In distribution | |
| LS-SC7G4550 | In distribution | |
| 0 | In distribution | |
| LS-SC7G7540 | In distribution | |
| 0 | In distribution | |
| LS-N6MG9545 | In distribution | |
| LS-RD60C080 | In distribution | |
| LS-SC7G7535 | In distribution | |
| LS-RD55F130 | In distribution | |
| 0 | In distribution | |
| LS-SC7G7560 | In distribution | |
| LS-N6SG5560 | In distribution | |
| 0 | In distribution | |
| 0 | In distribution | |
| LS-SC7G5045 | In distribution | |
| LS-N6MG4530 | In distribution | |
| 0 | In distribution | |
| 0 | In distribution | |
| LS-N6SG5050 | In distribution | |
| LS-N6MA8545 | In distribution | |
| 0 | In distribution | |
| LS-N6SG8550 | In distribution | |
| LS-CL6-3847 | In distribution | |
| LS-N6RG4525 | In distribution | |
| LS-N6SA6560 | In distribution | |
| 0 | In distribution | |
| LS-N6SE4520 | In distribution | |
| LS-N6SG8545 | In distribution | |
| 0 | In distribution | |
| LS-N6RG5520 | In distribution | |
| LS-N6MG6545 | In distribution | |
| LS-N6SR7500 | In distribution | |
| LS-SC7G1540 | In distribution | |
| LS-RD50E090 | In distribution | |
| LS-SC7G4555 | In distribution | |
| LS-RD55F100 | In distribution | |
| 0 | In distribution | |
| LS-SC7G5520 | In distribution | |
| LS-RD55B070 | In distribution | |
| LS-N6SE5560 | In distribution | |
| 0 | In distribution | |
| LS-N6SA5535 | In distribution | |
| 0 | In distribution | |
| 0 | In distribution | |
| LS-N6MA6535 | In distribution | |
| 0 | In distribution | |
| LS-N6SE5545 | In distribution | |
| LS-N6RG4535 | In distribution | |
| LS-N6SR1580 | In distribution | |
| LS-RD55C075 | In distribution | |
| LS-RD50G100 | In distribution | |
| LS-SC7L6550 | In distribution | |
| LS-RD55B035 | In distribution | |
| 0 | In distribution | |
| LS-CL6-5069 | In distribution | |
| LS-N6SG6530 | In distribution | |
| LS-RD55A100 | In distribution | |
| LS-N6RE6540 | In distribution | |
| LS-RD55A095 | In distribution | |
| LS-N6ME7545 | In distribution | |
| LS-N6SG7550 | In distribution | |
| LS-SC7L6520 | In distribution | |
| LS-IC55C75 | In distribution | |
| 0 | In distribution | |
| LS-SC7L6530 | In distribution | |
| LS-N6RE7535 | In distribution | |
| LS-N6SA5540 | In distribution | |
| LS-SC7G8555 | In distribution | |
| 0 | In distribution | |
| 0 | In distribution | |
| LS-N6RA6545 | In distribution | |
| LS-SC7L4560 | In distribution | |
| 0 | In distribution | |
| 0 | In distribution | |
| LS-N6SE5025 | In distribution | |
| LS-SC7G6525 | In distribution | |
| 0 | In distribution | |
| LS-N6RA1560 | In distribution | |
| LS-N6SG6540 | In distribution | |
| LS-N6SE6555 | In distribution | |
| LS-N6RA7535 | In distribution | |
| LS-N6MA6530 | In distribution | |
| LS-N6MG1540 | In distribution | |
| LS-N6SG5535 | In distribution | |
| 0 | In distribution | |
| 0 | In distribution | |
| LS-N6SE6540 | In distribution | |
| 0 | In distribution | |
| LS-RD55B080 | In distribution | |
| LS-N6SG8530 | In distribution | |
| LS-N6RE6550 | In distribution | |
| 0 | In distribution | |
| 0 | In distribution | |
| LS-RD55C085 | In distribution | |
| LS-RD55B095 | In distribution | |
| LS-N6RA4530 | In distribution | |
| LS-N6SE7545 | In distribution | |
| LS-N6RE4545 | In distribution | |
| LS-N6SR8570 | In distribution | |
| 0 | In distribution | |
| LS-SC7G8570 | In distribution | |
| LS-N6RA5040 | In distribution | |
| LS-N6SE5035 | In distribution | |
| LS-N6SA5035 | In distribution | |
| LS-N6SR9500 | In distribution | |
| LS-SC7G8500 | In distribution | |
| LS-RD55C080 | In distribution | |
| LS-N6SA4520 | In distribution | |
| LS-N6MA5530 | In distribution | |
| 0 | In distribution | |
| LS-SC7E7550 | In distribution | |
| LS-N6RA4535 | In distribution | |
| 0 | In distribution | |
| 0 | In distribution | |
| LS-N6SG9555 | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
| Vertex® Reconstruction System | Medtronic Sofamor Danek, Inc. | 830 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
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 |
|---|---|---|---|---|---|
| 2018-07-30 | Class II | Nonconforming Material/Component | The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue.These devices are indicated as an adjunct to fusion for various indications | 16,429 devices (Thoracolumbosacral pedicle screw system,Spin | 2021-04-28 |
| 2015-07-22 | Class II | Device Design | Biomet has initiated a recall on Biomet Spine Lineum OCC Starter Flexible and its inner shaft instrumentsafter identifying that these instruments were distributed prior to completion of all design control activities. | 49 | 2015-12-10 |
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.