Coalition MIS
The COALITION MIS spacer is an interbody fusion device used after cervical discectomy to provide structural stability. It is placed through an anterior cervical approach and is available in…
The COALITION MIS spacer is an interbody fusion device used after cervical discectomy to provide structural stability. It is placed through an anterior cervical approach and is available in different heights and geometries to fit patient anatomy.
For skeletally mature patients with cervical degenerative disc disease, the spacer is filled with bone graft and used with two titanium alloy screws or anchors. Screws permit stand-alone use at one or two C2-T1 levels; anchors require one-level use with additional fixation. Patients should have had at least six weeks of nonoperative treatment.
Listed Item
COALITION MIS Spacer, 12 x 14, 12°, 11mm
Fixation Options
The spacer’s superior and inferior protrusions grip adjacent vertebral endplates to resist expulsion. It can be used with screws or anchors, with different supplemental fixation arrangements.
5manufacturers in China registered for this device type
144catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Zhejiang (2), Guangdong (1), Jiangsu (1). 3 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 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Globus Medical, Inc., United States |
|---|---|
| FDA product code | OVE |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K151939 |
| Record published | 2016-02-27 |
| Record revised | 2025-07-14 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number |
| Sizes | Width 14 to 18 mm; depth 12 to 15 mm; height 5 to 12 mm; length 11 to 17 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1136.2408 | Width 14 mm | In distribution |
| 1136.2482 | Width 14 mm | In distribution |
| 1136.4697 | Lordosis 12 Degree | In distribution |
| 3136.4107 | Lordosis 7 Degree | In distribution |
| 3136.2007 | Height 7 mm | In distribution |
| 1136.5876 | Width 18 mm | In distribution |
| 1136.4699 | Lordosis 12 Degree | In distribution |
| 1136.5901 | Lordosis 12 Degree | In distribution |
| 3136.2006 | Depth 14 mm | In distribution |
| 1136.5807 | Height 7 mm | In distribution |
| 1136.2477 | Width 14 mm | In distribution |
| 3136.1110 | Width 14 mm | In distribution |
| 1136.4698 | Height 8 mm | In distribution |
| 3136.1607 | Depth 12 mm | In distribution |
| 1136.5878 | Width 18 mm | In distribution |
| 1136.5877 | Depth 15 mm | In distribution |
| 3136.4011 | Height 11 mm | In distribution |
| 3136.4106 | Lordosis 7 Degree | In distribution |
| 1136.2501 | Lordosis 12 Degree | In distribution |
| 3136.2005 | Depth 14 mm | In distribution |
| 3136.4105 | Width 18 mm | In distribution |
| 1136.5811 | Width 18 mm | In distribution |
| 3136.1611 | Depth 12 mm | In distribution |
| 3136.4008 | Width 18 mm | In distribution |
| 3136.2012 | Depth 14 mm | In distribution |
| 1136.2013 | Length 13 mm | In distribution |
| 3136.1006 | Height 6 mm | In distribution |
| 1136.5881 | Depth 15 mm | In distribution |
| 3136.4607 | Depth 15 mm | In distribution |
| 3136.1107 | Height 7 mm | In distribution |
| 1136.2480 | Width 14 mm | In distribution |
| 3136.4109 | Lordosis 7 Degree | In distribution |
| 3136.2107 | Width 16 mm | In distribution |
| 1136.4680 | Depth 14 mm | In distribution |
| 3136.4005 | Height 5 mm | In distribution |
| 1136.5880 | Lordosis 7 Degree | In distribution |
| 1136.5899 | Height 9 mm | In distribution |
| 1136.5879 | Depth 15 mm | In distribution |
| 1136.2502 | Depth 12 mm | In distribution |
| 3136.4006 | Height 6 mm | In distribution |
| 1136.2017 | Length 17 mm | In distribution |
| 1136.5898 | Height 8 mm | In distribution |
| 1136.2014 | Length 14 mm | In distribution |
| 1136.4675 | Height 5 mm | In distribution |
| 1136.4408 | Depth 14 mm | In distribution |
| 1136.2478 | Depth 12 mm | In distribution |
| 3136.1105 | Depth 12 mm | In distribution |
| 3136.1608 | Lordosis 12 Degree | In distribution |
| 1136.2476 | Lordosis 7 Degree | In distribution |
| 3136.2009 | Width 16 mm | In distribution |
| 3136.2610 | Lordosis 12 Degree | In distribution |
| 1136.5902 | Lordosis 12 Degree | In distribution |
| 3136.4611 | Height 11 mm | In distribution |
| 1136.4407 | Width 16 mm | In distribution |
| 1136.4676 | Width 16 mm | In distribution |
| 3136.4010 | Width 18 mm | In distribution |
| 1136.4412 | Depth 14 mm | In distribution |
| 3136.2008 | Depth 14 mm | In distribution |
| 3136.4108 | Width 18 mm | In distribution |
| 3136.4111 | Lordosis 7 Degree | In distribution |
| 1136.4409 | Depth 14 mm | In distribution |
| 3136.2105 | Height 5 mm | In distribution |
| 3136.4110 | Width 18 mm | In distribution |
| 3136.4009 | Height 9 mm | In distribution |
| 1136.4678 | Height 8 mm | In distribution |
| 3136.4112 | Lordosis 7 Degree | In distribution |
| 3136.2010 | Height 10 mm | In distribution |
| 3136.1612 | Lordosis 12 Degree | In distribution |
| 1136.2498 | Depth 12 mm | In distribution |
| 3136.2109 | Depth 14 mm | In distribution |
| 1136.2500 | Width 14 mm | In distribution |
| 1136.2499 | Height 9 mm | In distribution |
| 3136.2612 | Depth 14 mm | In distribution |
| 3136.1012 | Height 12 mm | In distribution |
| 3136.2608 | Depth 14 mm | In distribution |
| 1136.2011 | Length 11 mm | In distribution |
| 3136.2111 | Lordosis 7 Degree | In distribution |
| 1136.4677 | Height 7 mm | In distribution |
| 1136.5812 | Height 12 mm | In distribution |
| 1136.5896 | Width 18 mm | In distribution |
| 1136.2015 | Length 15 mm | In distribution |
| 1136.4681 | Depth 14 mm | In distribution |
| 3136.1108 | Height 8 mm | In distribution |
| 3136.1609 | Height 9 mm | In distribution |
| 1136.4696 | Lordosis 12 Degree | In distribution |
| 3136.1007 | Depth 12 mm | In distribution |
| 1136.2410 | Depth 12 mm | In distribution |
| 1136.4406 | Width 16 mm | In distribution |
| 1136.2409 | Height 9 mm | In distribution |
| 1136.4682 | Depth 14 mm | In distribution |
| 1136.2405 | Height 5 mm | In distribution |
| 1136.4410 | Height 10 mm | In distribution |
| 1136.2479 | Width 14 mm | In distribution |
| 3136.2606 | Height 6 mm | In distribution |
| 3136.1109 | Height 9 mm | In distribution |
| 1136.4679 | Height 9 mm | In distribution |
| 1136.4700 | Width 16 mm | In distribution |
| 1136.5810 | Height 10 mm | In distribution |
| 3136.1008 | Height 8 mm | In distribution |
| 3136.1610 | Width 14 mm | In distribution |
| 1136.5900 | Width 18 mm | In distribution |
| 3136.2108 | Height 8 mm | In distribution |
| 3136.4606 | Depth 15 mm | In distribution |
| 3136.2609 | Depth 14 mm | In distribution |
| 3136.1111 | Depth 12 mm | In distribution |
| 3136.2607 | Height 7 mm | In distribution |
| 3136.4608 | Depth 15 mm | In distribution |
| 1136.2016 | Length 16 mm | In distribution |
| 1136.5875 | Depth 15 mm | In distribution |
| 3136.1009 | Width 14 mm | In distribution |
| 1136.2012 | Length 12 mm | In distribution |
| 3136.4012 | Depth 15 mm | In distribution |
| 3136.1112 | Width 14 mm | In distribution |
| 3136.4609 | Depth 15 mm | In distribution |
| 1136.5806 | Width 18 mm | In distribution |
| 3136.4007 | Height 7 mm | In distribution |
| 3136.2011 | Width 16 mm | In distribution |
| 3136.2611 | Depth 14 mm | In distribution |
| 3136.4612 | Width 18 mm | In distribution |
| 1136.2475 | Width 14 mm | In distribution |
| 1136.4411 | Height 11 mm | In distribution |
| 1136.2406 | Depth 12 mm | In distribution |
| 1136.5809 | Depth 15 mm | In distribution |
| 3136.2110 | Height 10 mm | In distribution |
| 1136.2412 | Height 12 mm | In distribution |
| 1136.2496 | Width 14 mm | In distribution |
| 1136.2411 | Width 14 mm | In distribution |
| 3136.1011 | Depth 12 mm | In distribution |
| 3136.1010 | Width 14 mm | In distribution |
| 1136.4701 | Height 11 mm | In distribution |
| 1136.5808 | Depth 15 mm | In distribution |
| 1136.5882 | Width 18 mm | In distribution |
| 3136.4610 | Height 10 mm | In distribution |
| 1136.2481 | Lordosis 7 Degree | In distribution |
| 3136.2112 | Depth 14 mm | In distribution |
| 3136.1106 | Depth 12 mm | In distribution |
| 1136.5897 | Width 18 mm | In distribution |
| 1136.2407 | Width 14 mm | In distribution |
| 3136.2106 | Depth 14 mm | In distribution |
| 1136.2497 | Depth 12 mm | In distribution |
| 1136.4702 | Depth 14 mm | In distribution |
| 1136.4405 | Depth 14 mm | In distribution |
| 3136.1606 | Lordosis 12 Degree | In distribution |
| 1136.5805 | Height 5 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| IdentiTi | Alphatec Spine, Inc. | 630 |
| Dolomite | Astura Medical | 607 |
| CoRoent | Nuvasive, Inc. | 580 |
| Aeon-C | Diomedical Co., Ltd. | 508 |
| Tomcat™ Cervical Spinal System | Choice Spine, LP | 468 |
| Shoreline ACS | Seaspine Orthopedics Corporation | 428 |
| Zavation | Zavation | 423 |
| Alta™ Stand-Alone Interbody Fusion System | Biomet Spine | 404 |
| Unison™-C Anterior Cervical Fixation System | Pioneer Surgical Technology, Inc. | 334 |
| Chesapeake® Stabilization System | VB Spine LLC | 272 |
| UniSpace® Stand-Alone C Cage | CG MedTech Co., Ltd. | 260 |
| Solitaire-C Cervical Spacer | Biomet Spine | 256 |
Showing 12 of 391. All products under Intervertebral Fusion Device With Integrated Fixation, Cervical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253876 | 2025-12-22 |
| K151939 | 2016-01-29 |
| K131449 | 2013-07-30 |
| K083389 | 2009-03-26 |
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.