Coalition
4.2mm Bone Screw, Variable, Self-Drilling, 18mm
7manufacturers in China registered for this device type
100catalogue numbers in this listing
7510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (2), Shandong (2), Zhejiang (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
| Shanghai Sanyou Medical Co., Ltd. | Shanghai | Shanghai | Manufacturer | 6 |
Record
| Listed by | Globus Medical, Inc., United States |
|---|---|
| FDA product code | ODP |
| Device type | Intervertebral Fusion Device With Bone Graft, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K083389 |
| Record published | 2015-11-07 |
| Record revised | 2025-07-14 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number |
| Sizes | Height 5 to 12 mm; width 14 to 20 mm; depth 12 to 16 mm; length 12 to 20 mm; outer diameter 3.6 to 4.2 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 184.118 | Length 18 mm | In distribution |
| 184.114 | Outer Diameter 3.6 mm | In distribution |
| 384.137 | Height 7 mm | In distribution |
| 184.080 | Outer Diameter 4.2 mm | In distribution |
| 384.122 | Lordosis 7 Degree | In distribution |
| 384.136 | Depth 16 mm | In distribution |
| 384.630 | Width 18 mm | In distribution |
| 384.409 | Width 18 mm | In distribution |
| 384.030 | Width 14 mm | In distribution |
| 184.058 | Outer Diameter 4.2 mm | In distribution |
| 184.112 | Outer Diameter 3.6 mm | In distribution |
| 384.512 | Width 18 mm | In distribution |
| 184.140 | Length 20 mm | In distribution |
| 384.306 | Height 6 mm | In distribution |
| 184.120 | Outer Diameter 3.6 mm | In distribution |
| 384.026 | Width 14 mm | In distribution |
| 384.410 | Width 18 mm | In distribution |
| 384.119 | Depth 14 mm | In distribution |
| 384.405 | Height 5 mm | In distribution |
| 384.212 | Depth 14 mm | In distribution |
| 184.158 | Length 18 mm | In distribution |
| 384.005 | Width 14 mm | In distribution |
| 384.135 | Lordosis 7 Degree | In distribution |
| 384.018 | Height 8 mm | In distribution |
| 384.411 | Depth 15 mm | In distribution |
| 184.020 | Length 20 mm | In distribution |
| 184.136 | Outer Diameter 3.6 mm | In distribution |
| 384.509 | Height 9 mm | In distribution |
| 384.112 | Depth 12 mm | In distribution |
| 384.111 | Height 11 mm | In distribution |
| 384.128 | Width 14 mm | In distribution |
| 384.041 | Height 11 mm | In distribution |
| 184.076 | Outer Diameter 4.2 mm | In distribution |
| 384.206 | Width 16 mm | In distribution |
| 384.021 | Width 14 mm | In distribution |
| 184.132 | Outer Diameter 3.6 mm | In distribution |
| 184.038 | Outer Diameter 4.2 mm | In distribution |
| 384.110 | Depth 12 mm | In distribution |
| 384.040 | Width 20 mm | In distribution |
| 384.632 | Height 12 mm | In distribution |
| 384.617 | Depth 14 mm | In distribution |
| 184.152 | Length 12 mm | In distribution |
| 384.118 | Width 14 mm | In distribution |
| 184.016 | Outer Diameter 4.2 mm | In distribution |
| 184.078 | Length 18 mm | In distribution |
| 384.008 | Depth 12 mm | In distribution |
| 184.054 | Length 14 mm | In distribution |
| 184.018 | Length 18 mm | In distribution |
| 384.115 | Height 5 mm | In distribution |
| 384.017 | Depth 14 mm | In distribution |
| 384.616 | Depth 14 mm | In distribution |
| 184.154 | Outer Diameter 3.6 mm | In distribution |
| 184.040 | Outer Diameter 4.2 mm | In distribution |
| 384.120 | Height 10 mm | In distribution |
| 384.007 | Height 7 mm | In distribution |
| 6128.4111 | Height 11 mm | In distribution |
| 384.626 | Lordosis 12 Degree | In distribution |
| 184.052 | Length 12 mm | In distribution |
| 184.116 | Length 16 mm | In distribution |
| 384.309 | Height 9 mm | In distribution |
| 184.014 | Outer Diameter 4.2 mm | In distribution |
| 184.134 | Length 14 mm | In distribution |
| 384.611 | Lordosis 12 Degree | In distribution |
| 184.060 | Length 20 mm | In distribution |
| 184.138 | Length 18 mm | In distribution |
| 184.180 | Length 20 mm | In distribution |
| 184.056 | Length 16 mm | In distribution |
| 384.310 | Depth 14 mm | In distribution |
| 384.032 | Width 14 mm | In distribution |
| 184.072 | Length 12 mm | In distribution |
| 384.130 | Height 10 mm | In distribution |
| 384.618 | Lordosis 12 Degree | In distribution |
| 384.025 | Width 14 mm | In distribution |
| 384.638 | Lordosis 12 Degree | In distribution |
| 384.508 | Width 18 mm | In distribution |
| 184.074 | Outer Diameter 4.2 mm | In distribution |
| 384.208 | Width 16 mm | In distribution |
| 384.106 | Lordosis 7 Degree | In distribution |
| 384.610 | Depth 12 mm | In distribution |
| 384.511 | Height 11 mm | In distribution |
| 384.131 | Depth 16 mm | In distribution |
| 384.132 | Depth 16 mm | In distribution |
| 184.156 | Length 16 mm | In distribution |
| 184.034 | Outer Diameter 4.2 mm | In distribution |
| 184.012 | Length 12 mm | In distribution |
| 184.032 | Outer Diameter 4.2 mm | In distribution |
| 184.172 | Length 12 mm | In distribution |
| 384.636 | Depth 16 mm | In distribution |
| 384.628 | Lordosis 12 Degree | In distribution |
| 184.160 | Length 20 mm | In distribution |
| 384.307 | Width 16 mm | In distribution |
| 184.178 | Length 18 mm | In distribution |
| 384.029 | Height 9 mm | In distribution |
| 184.176 | Outer Diameter 3.6 mm | In distribution |
| 184.174 | Length 14 mm | In distribution |
| 184.036 | Length 16 mm | In distribution |
| 384.620 | Depth 14 mm | In distribution |
| 384.209 | Width 16 mm | In distribution |
| 384.408 | Depth 15 mm | In distribution |
| 384.507 | Depth 15 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Latitude-C AM™ Cervical Interbody Fusion System | Degen Medical | 1,529 |
| IdentiTi | Alphatec Spine, Inc. | 1,390 |
| Zavation | Zavation | 1,357 |
| IVA Cage Ti | Diomedical Co., Ltd. | 1,202 |
| Latitude-C Cervical Interbody Spacer System | Degen Medical | 1,185 |
| Peridot Anterior Cervical Intervertebral Body Fusion System | Gbs Commonwealth Co., Ltd. | 1,056 |
| Aleutian® Interbody Systems | VB Spine LLC | 1,017 |
| Valeo Spacer System | Sintx Technologies Inc. | 918 |
| Cascadia™ Interbody System | VB Spine LLC | 823 |
| CoRoent | Nuvasive, Inc. | 815 |
| Tyber Medical | Tyber Medical | 740 |
| Matisse Anterior Cervical Interbody Fusion Cage System | CTL Medical Corporation | 577 |
Showing 12 of 938. All products under Intervertebral Fusion Device With Bone Graft, Cervical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K222270 | 2022-10-21 |
| K191243 | 2019-09-17 |
| K180909 | 2018-12-18 |
| K173722 | 2018-05-23 |
| K173115 | 2017-12-20 |
| K142218 | 2015-03-31 |
| K072991 | 2008-01-18 |
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.