LITe Plate System
The LITe Universal Plate is a titanium alloy component used with screws to provide additional support during spinal fusion. The system offers several plate sizes for different anatomies. It…
The LITe Universal Plate is a titanium alloy component used with screws to provide additional support during spinal fusion. The system offers several plate sizes for different anatomies. It is intended for skeletally mature patients with specified thoracic, lumbar or sacral instability or deformity.
Universal plates can be placed laterally or anterolaterally above the great vessel bifurcation for T1 to L5 treatment. Below the bifurcation, an anterior approach applies to L1 to S1. Those anatomical and approach conditions determine the intended fixation region.
Listed Item
1 Level Universal Plate
System Indications
Indications include degenerative disc disease, pseudoarthrosis, spondylolysis, spondylolisthesis, stenosis, tumors, trauma, spinal deformity and failed fusion. Universal plates are separate from the LITe Buttress Plate, whose stated role is stabilizing bone graft at one level and whose use excludes load-bearing applications.
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| 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 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| 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 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 14. All 14 manufacturers in China registered for Appliance, Fixation, Spinal Intervertebral Body
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K142699 |
| Record published | 2015-09-14 |
| Record revised | 2025-11-20 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Length 16 to 60 mm |
| Distribution end date | 2025-03-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 49170135 | Length 35.0 mm | In distribution |
| 49175540 | Diameter: 5.5 Millimeter | Withdrawn |
| 49171125 | Length 25.0 mm | Withdrawn |
| 49174124 | Length 24.0 mm | Withdrawn |
| 49175034 | Length 34.0 mm | Withdrawn |
| 49173116 | Length 16.0 mm | Withdrawn |
| 49175025 | Length 25.0 mm | Withdrawn |
| 49174122 | Length 22.0 mm | Withdrawn |
| 49175056 | Length 56.0 mm | Withdrawn |
| 49171135 | Length 35.0 mm | Withdrawn |
| 49175556 | Diameter: 5.5 Millimeter | Withdrawn |
| 49175522 | Diameter: 5.5 Millimeter | Withdrawn |
| 49175044 | Diameter: 5.0 Millimeter | Withdrawn |
| 49175552 | Diameter: 5.5 Millimeter | Withdrawn |
| 49171123 | Length 23.0 mm | Withdrawn |
| 49175060 | Diameter: 5.0 Millimeter | Withdrawn |
| 49170137 | Length 37.0 mm | Withdrawn |
| 49175525 | Diameter: 5.5 Millimeter | Withdrawn |
| 49175040 | Diameter: 5.0 Millimeter | Withdrawn |
| 49172100 | Withdrawn | |
| 49173118 | Length 18.0 mm | Withdrawn |
| 49170125 | Length 25.0 mm | Withdrawn |
| 49175560 | Diameter: 5.5 Millimeter | Withdrawn |
| 49170131 | Length 31.0 mm | Withdrawn |
| 49173126 | Length 24.0 mm | Withdrawn |
| 49175022 | Diameter: 5.0 Millimeter | Withdrawn |
| 49171133 | Length 33.0 mm | Withdrawn |
| 49175531 | Diameter: 5.5 Millimeter | Withdrawn |
| 49174120 | Length 20.0 mm | Withdrawn |
| 49175031 | Diameter: 5.0 Millimeter | Withdrawn |
| 49175037 | Length 37.0 mm | Withdrawn |
| 49175052 | Diameter: 5.0 Millimeter | Withdrawn |
| 49174128 | Length 28.0 mm | Withdrawn |
| 49171129 | Length 29.0 mm | Withdrawn |
| 49174118 | Length 18.0 mm | Withdrawn |
| 49175028 | Diameter: 5.0 Millimeter | Withdrawn |
| 49173128 | Length 28.0 mm | Withdrawn |
| 49175048 | Diameter: 5.0 Millimeter | Withdrawn |
| 49171137 | Length 37.0 mm | Withdrawn |
| 49170127 | Length 27.0 mm | Withdrawn |
| 49175548 | Length 48.0 mm | Withdrawn |
| 49171131 | Length 31.0 mm | Withdrawn |
| 49170133 | Length 33.0 mm | Withdrawn |
| 49174126 | Length 26.0 mm | Withdrawn |
| 49173122 | Length 20.0 mm | Withdrawn |
| 49170123 | Length 23.0 mm | Withdrawn |
| 49173124 | Length 26.0 mm | Withdrawn |
| 49170121 | Length 21.0 mm | Withdrawn |
| 49171127 | Length 27.0 mm | Withdrawn |
| 49170129 | Length 29.0 mm | Withdrawn |
| 49175528 | Length 28.0 mm | Withdrawn |
| 49175534 | Diameter: 5.5 Millimeter | Withdrawn |
| 49175537 | Diameter: 5.5 Millimeter | Withdrawn |
| 49175544 | Length 44.0 mm | Withdrawn |
| 49173120 | Length 22.0 mm | Withdrawn |
| 49171121 | Length 21.0 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 2,998 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,568 |
| Creo | Globus Medical, Inc. | 1,765 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 1,755 |
| Ozark Cervical Plate System | VB Spine LLC | 1,460 |
| Sirion | Astura Medical | 1,246 |
| Apex Spine System | Spinecraft LLC | 1,187 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 986 |
| Astra Spine System | Spinecraft LLC | 970 |
| Zavation | Zavation | 966 |
| ACP | Nuvasive, Inc. | 918 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 877 |
Showing 12 of 855. All products under Appliance, Fixation, Spinal Intervertebral Body
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K221728 | 2022-10-19 |
| K150700 | 2015-07-15 |
| K150449 | 2015-03-20 |
| K142237 | 2015-01-26 |
| K142699 | 2014-12-31 |
| K083020 | 2009-03-26 |
| K083562 | 2009-03-25 |
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.