Oria Zenith® Cervical Plate System
ZENITH,PLATE,1Level,29
11manufacturers in China registered for this device type
26catalogue 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 | Choice Spine, LP |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| 510(k) | K001535 |
| Record published | 2015-10-24 |
| Record revised | 2025-11-20 (version 5) |
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 |
| Sizes | Length 23 to 97 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FT20-E229 | Length 29 mm | In distribution |
| FT20-E231 | Length 31 mm | In distribution |
| FT20-E227 | Length 27 mm | In distribution |
| FT20-E337 | Length 37 mm | In distribution |
| FT20-E349 | Length 49 mm | In distribution |
| FT20-E461 | Length 61 mm | In distribution |
| FT20-E470 | Length 70 mm | In distribution |
| FT20-E333 | Length 33 mm | In distribution |
| FT20-E455 | Length 55 mm | In distribution |
| FT20-E225 | Length 25 mm | In distribution |
| FT20-E223 | Length 23 mm | In distribution |
| FT20-E341 | Length 41 mm | In distribution |
| FT20-E343 | Length 43 mm | In distribution |
| FT20-E345 | Length 45 mm | In distribution |
| FT20-E351 | Length 51 mm | In distribution |
| FT20-E353 | Length 53 mm | In distribution |
| FT20-E597 | Length 97 mm | In distribution |
| FT20-E573 | Length 73 mm | In distribution |
| FT20-E339 | Length 39 mm | In distribution |
| FT20-E467 | Length 67 mm | In distribution |
| FT20-E335 | Length 35 mm | In distribution |
| FT20-E458 | Length 58 mm | In distribution |
| FT20-E347 | Length 47 mm | In distribution |
| FT20-E589 | Length 89 mm | In distribution |
| FT20-E464 | Length 64 mm | In distribution |
| FT20-E581 | Length 81 mm | 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.