Hedron
HEDRON C-MIS Spacer, 15x18, 11mm, 12°
5manufacturers in China registered for this device type
68catalogue 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) | K191243 |
| Record published | 2019-11-13 |
| Record revised | 2025-07-14 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Depth 8 to 10.5 mm; width 14 to 18 mm; height 5 to 12 mm; angle 7 to 12 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1213.6082S | Depth 10 mm | In distribution |
| 1406.2407S | In distribution | |
| 1406.2496S | In distribution | |
| 1406.4612S | In distribution | |
| 1406.4611S | In distribution | |
| 1213.6091S | Height 11 mm | In distribution |
| 1213.6090S | Width 16 mm | In distribution |
| 1406.2478S | In distribution | |
| 1406.5898S | In distribution | |
| 1406.4607S | In distribution | |
| 1406.5879S | In distribution | |
| 1406.5901S | In distribution | |
| 1406.2477S | In distribution | |
| 1406.2475S | In distribution | |
| 1406.4678S | In distribution | |
| 1406.4608S | In distribution | |
| 1213.4091S | Angle 12 ° | In distribution |
| 1213.8078S | Width 18 mm | In distribution |
| 1213.8010S | Height 10 mm | In distribution |
| 1406.5900S | In distribution | |
| 1406.5896S | In distribution | |
| 1213.6086S | Depth 10 mm | In distribution |
| 1406.5811S | In distribution | |
| 1406.5810S | In distribution | |
| 1213.4092S | Width 14 mm | In distribution |
| 1213.6011S | Width 16 mm | In distribution |
| 1406.4676S | In distribution | |
| 1213.4078S | Depth 8 mm | In distribution |
| 1406.4677S | In distribution | |
| 1213.6092S | Height 12 mm | In distribution |
| 1213.8075S | Width 18 mm | In distribution |
| 1406.2479S | In distribution | |
| 1406.4679S | In distribution | |
| 1406.2481S | In distribution | |
| 1213.6076S | Height 6 mm | In distribution |
| 1213.8081S | Depth 10.5 mm | In distribution |
| 1213.8005S | Depth 10.5 mm | In distribution |
| 1406.4680S | In distribution | |
| 1406.5806S | In distribution | |
| 1213.8076S | Height 6 mm | In distribution |
| 1406.5875S | In distribution | |
| 1213.4011S | Depth 8 mm | In distribution |
| 1406.2411S | In distribution | |
| 1406.5878S | In distribution | |
| 1406.2497S | In distribution | |
| 1406.2476S | In distribution | |
| 1213.6077S | Height 7 mm | In distribution |
| 1406.5808S | In distribution | |
| 1213.6078S | Width 16 mm | In distribution |
| 1213.8080S | Depth 10.5 mm | In distribution |
| 1406.2412S | In distribution | |
| 1406.2405S | In distribution | |
| 1213.6080S | Depth 10 mm | In distribution |
| 1213.4010S | Depth 8 mm | In distribution |
| 1213.4012S | Depth 8 mm | In distribution |
| 1213.8086S | Depth 10.5 mm | In distribution |
| 1213.4090S | Depth 8 mm | In distribution |
| 1213.6075S | Depth 10 mm | In distribution |
| 1406.4701S | In distribution | |
| 1406.5899S | In distribution | |
| 1406.2410S | In distribution | |
| 1213.8087S | Width 18 mm | In distribution |
| 1406.4697S | In distribution | |
| 1406.4610S | In distribution | |
| 1406.2408S | In distribution | |
| 1213.6005S | Height 5 mm | In distribution |
| 1213.8091S | Angle 12 ° | In distribution |
| 1406.2482S | 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.