Coalition
COALITION ACDF Trial, 12° Lordotic , 12x14 - 10mm
53manufacturers in China registered for this device type
41catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (24), Guangdong (7), Zhejiang (6). 29 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
Showing 12 of 53. All 53 manufacturers in China registered for Orthopedic Manual Surgical Instrument
Record
| Listed by | Globus Medical, Inc., United States |
|---|---|
| FDA product code | LXH |
| Device type | Orthopedic Manual Surgical Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K131449 |
| Record published | 2016-10-07 |
| Record revised | 2024-09-11 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
| Sizes | Height 5 to 12 mm; width 14 to 20 mm; depth 12 to 16 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 684.730 | Width 14 mm | In distribution |
| 684.749 | Height 9 mm | In distribution |
| 6128.4011 | Height 11 mm | In distribution |
| 684.731 | Lordosis 12 Degree | In distribution |
| 6128.4006 | Height 6 mm | In distribution |
| 684.737 | Height 7 mm | In distribution |
| 6128.4012 | Height 12 mm | In distribution |
| 684.740 | Width 16 mm | In distribution |
| 6128.4009 | Height 9 mm | In distribution |
| 684.748 | Depth 15 mm | In distribution |
| 684.742 | Depth 14 mm | In distribution |
| 684.759 | Depth 16 mm | In distribution |
| 6128.4007 | Height 7 mm | In distribution |
| 6128.4010 | Height 10 mm | In distribution |
| 684.738 | Width 16 mm | In distribution |
| 684.762 | Depth 16 mm | In distribution |
| 684.751 | Depth 15 mm | In distribution |
| 684.739 | Height 9 mm | In distribution |
| 684.758 | Height 8 mm | In distribution |
| 684.741 | Depth 14 mm | In distribution |
| 6128.4005 | Height 5 mm | In distribution |
| 684.715 | Height 5 mm | In distribution |
| 684.750 | Width 18 mm | In distribution |
| 684.736 | Width 16 mm | In distribution |
| 684.165 | Width 16 mm | In distribution |
| 6128.4008 | Height 8 mm | In distribution |
| 684.155 | Width 14 mm | In distribution |
| 684.729 | Lordosis 12 Degree | In distribution |
| 684.726 | Height 6 mm | In distribution |
| 684.175 | Width 18 mm | In distribution |
| 684.727 | Width 14 mm | In distribution |
| 684.752 | Width 18 mm | In distribution |
| 684.761 | Depth 16 mm | In distribution |
| 684.757 | Depth 16 mm | In distribution |
| 684.756 | Depth 16 mm | In distribution |
| 684.705 | Width 20 mm | In distribution |
| 684.760 | Width 20 mm | In distribution |
| 684.747 | Lordosis 12 Degree | In distribution |
| 684.746 | Depth 15 mm | In distribution |
| 684.728 | Lordosis 12 Degree | In distribution |
| 684.732 | Width 14 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Razek Equipamentos | Razek Equipamentos Ltda | 11,578 |
| Orthopedic Manual Surgical Instrument | Globus Medical, Inc. | 4,784 |
| Instrument | Howmedica Osteonics Corp | 4,539 |
| Orthopedic Manual Surgical Instrument | Ortho Development Corp. | 4,076 |
| Knee Instruments | Medacta International SA | 3,944 |
| Kyocera Medical Technologies, Inc. | Kyocera Medical Technologies, Inc. | 3,420 |
| Arthrex® | Arthrex, Inc. | 3,106 |
| Spine Instruments | Medacta International SA | 2,892 |
| Orthopedic Manual Surgical Instrument | Medtronic Sofamor Danek, Inc. | 2,766 |
| Hip Instruments | Medacta International SA | 1,904 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 1,756 |
| ReLine | Nuvasive, Inc. | 1,208 |
Showing 12 of 9,501. All products under Orthopedic Manual Surgical Instrument
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.