Omni
5.5mm x 140mm Straight Rod (00607-140)
13manufacturers in China registered for this device type
105catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (2), Shandong (2). 4 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 |
| 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 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Changzhou Yonghua Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
Showing 12 of 13. All 13 manufacturers in China registered for Orthosis, Spondylolisthesis Spinal Fixation
Record
| Listed by | Spinal Elements, Inc., United States |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2017-06-27 |
| Record revised | 2025-07-02 (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 |
| Distribution end date | 2023-12-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LCT 35-K | In distribution | |
| LCT70 | In distribution | |
| LCT7045 | In distribution | |
| CT05050 | In distribution | |
| T70140 | In distribution | |
| CT07050 | In distribution | |
| LCPT 150-K | In distribution | |
| LCPT 140-K | In distribution | |
| LCT130-K | In distribution | |
| LCPT 35-K | In distribution | |
| T70130 | In distribution | |
| CT07040 | In distribution | |
| LCT50-F-C | In distribution | |
| LCPT 120-K | In distribution | |
| T70600 | In distribution | |
| CT07035 | In distribution | |
| CT06055 | In distribution | |
| CT07045 | In distribution | |
| FT06030 | In distribution | |
| FT05035 | In distribution | |
| LCPT 30-K | In distribution | |
| T70110 | In distribution | |
| FT05030 | In distribution | |
| LCPT 40-K | In distribution | |
| LCT50 | In distribution | |
| LCPT 80-K | In distribution | |
| CT07055 | In distribution | |
| LCPT 90-K | In distribution | |
| CT06045 | In distribution | |
| FT05040 | In distribution | |
| FT06035 | In distribution | |
| T70100 | In distribution | |
| LCT300 | In distribution | |
| CT06050 | In distribution | |
| T70500 | In distribution | |
| LCPT 75-K | In distribution | |
| T04040 | In distribution | |
| CT05040 | In distribution | |
| CT05035 | In distribution | |
| LCPT 45-K | In distribution | |
| CT06035 | In distribution | |
| FT06045 | In distribution | |
| FT05045 | In distribution | |
| T10100 | In distribution | |
| LCPT 50-K | In distribution | |
| LCPT 65-K | In distribution | |
| T80035-C | In distribution | |
| LCPT 130-K | In distribution | |
| FT06040 | In distribution | |
| RTS07045 | In distribution | |
| LCPT 60-K | In distribution | |
| T90030 | In distribution | |
| T86075 | In distribution | |
| CT05045 | In distribution | |
| LCPT 55-K | In distribution | |
| T04545 | In distribution | |
| LCPT 100-K | In distribution | |
| LCPT 110-K | In distribution | |
| LCPT 70-K | In distribution | |
| CT05055 | In distribution | |
| LCT80-K | Withdrawn | |
| LCT40-F-C | Withdrawn | |
| LCT5030 | Withdrawn | |
| T80050-C | Withdrawn | |
| LCT4530 | Withdrawn | |
| LCT4535 | Withdrawn | |
| LCT8040 | Withdrawn | |
| LCT7040 | Withdrawn | |
| LCT60-F-C | Withdrawn | |
| LCT80-F-C | Withdrawn | |
| LCT110-K | Withdrawn | |
| LCT5040 | Withdrawn | |
| LCT45-F-C | Withdrawn | |
| LCT70-K | Withdrawn | |
| LCT120-F-C | Withdrawn | |
| LCT95-F-C | Withdrawn | |
| lct7030 | Withdrawn | |
| LCT50-K | Withdrawn | |
| LCT5045 | Withdrawn | |
| LCT6045 | Withdrawn | |
| LCT70-F-C | Withdrawn | |
| LCT100-F-C | Withdrawn | |
| LCT7035 | Withdrawn | |
| LCT90-K | Withdrawn | |
| LCT8035 | Withdrawn | |
| LCT5035 | Withdrawn | |
| LCT55-K | Withdrawn | |
| LCT150-K | Withdrawn | |
| LCT6040 | Withdrawn | |
| LCT110-F-C | Withdrawn | |
| LCT5050 | Withdrawn | |
| LCT35-K | Withdrawn | |
| LCT8045 | Withdrawn | |
| LCT120-K | Withdrawn | |
| LCT7050 | Withdrawn | |
| LCT45-K | Withdrawn | |
| LCT85-F-C | Withdrawn | |
| LCT7055 | Withdrawn | |
| LCT6030 | Withdrawn | |
| LCT55-F-C | Withdrawn | |
| LCT60-K | Withdrawn | |
| LCT8050 | Withdrawn | |
| LCT90-F-C | Withdrawn | |
| LCT40-K | Withdrawn | |
| LCT140-K | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,144 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 2,177 |
| ReLine | Nuvasive, Inc. | 2,010 |
| Creo | Globus Medical, Inc. | 1,619 |
| Perfix™ Spinal System | CG MedTech Co., Ltd. | 1,476 |
| Apex Spine System | Spinecraft LLC | 1,193 |
| Olympic | Astura Medical | 1,173 |
| Arsenal | Alphatec Spine, Inc. | 1,001 |
| Revere | Globus Medical, Inc. | 997 |
| Astra Spine System | Spinecraft LLC | 798 |
| Apex-DL Spine System | Spinecraft LLC | 735 |
| Zenius Spinal System | Medyssey Co., Ltd. | 712 |
Showing 12 of 811. All products under Orthosis, Spondylolisthesis Spinal Fixation
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.