Hedron
Hedron is the listed name associated with Globus Medical’s HEDRON Cervical Spacers. The FDA filing describes anterior cervical interbody fusion spacers used to provide structural stability…
Hedron is the listed name associated with Globus Medical’s HEDRON Cervical Spacers. The FDA filing describes anterior cervical interbody fusion spacers used to provide structural stability following discectomy.
The filing identifies HEDRON C and HEDRON IC spacers for use at one or more cervical spine levels from C2 to T1. They are intended for skeletally mature patients and use with supplemental fixation.
Listed Item
HEDRON C-MIS Spacer, 12×14, 12mm, 12°
Device Function and Details
The spacers are additively manufactured from titanium alloy. The filing says they are filled with autograft and/or allogenic bone graft.
7manufacturers in China registered for this device type
177catalogue 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) | K191243 |
| Record published | 2020-01-18 |
| 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 15 mm; width 14 to 18 mm; height 5 to 12 mm; angle 7 to 20 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1211.4612S | Depth 14 mm | In distribution |
| 1211.4630S | Angle 12 ° | In distribution |
| 1213.6010S | Depth 10 mm | In distribution |
| 1211.4629S | Height 9 mm | In distribution |
| 1211.4616S | Depth 14 mm | In distribution |
| 1211.2451S | Width 14 mm | In distribution |
| 1211.5841S | Width 18 mm | In distribution |
| 1213.8008S | Depth 10.5 mm | In distribution |
| 1211.4607S | Depth 14 mm | In distribution |
| 1211.2420S | Angle 7 ° | In distribution |
| 1213.4075S | Height 5 mm | In distribution |
| 1211.2440S | Depth 12 mm | In distribution |
| 1211.2439S | Angle 15 ° | In distribution |
| 1406.4682S | In distribution | |
| 1211.5851S | Angle 20 ° | In distribution |
| 1213.4085S | Height 5 mm | In distribution |
| 1406.5805S | In distribution | |
| 1211.2418S | Depth 12 mm | In distribution |
| 1211.2437S | Height 7 mm | In distribution |
| 1211.5811S | Height 11 mm | In distribution |
| 1211.4621S | Angle 7 ° | In distribution |
| 1211.5820S | Depth 15 mm | In distribution |
| 1211.4620S | Height 10 mm | In distribution |
| 1213.4008S | Width 14 mm | In distribution |
| 1213.4007S | Height 7 mm | In distribution |
| 1213.4077S | Height 7 mm | In distribution |
| 1213.6007S | Height 7 mm | In distribution |
| 1211.2452S | Width 14 mm | In distribution |
| 1211.4610S | Height 10 mm | In distribution |
| 1211.2409S | Depth 12 mm | In distribution |
| 1211.2442S | Angle 15 ° | In distribution |
| 1213.6088S | Angle 12 ° | In distribution |
| 1406.4605S | In distribution | |
| 1211.2431S | Width 14 mm | In distribution |
| 1213.6009S | Height 9 mm | In distribution |
| 1213.4088S | Width 14 mm | In distribution |
| 1211.4608S | Height 8 mm | In distribution |
| 1213.4009S | Height 9 mm | In distribution |
| 1211.4631S | Height 11 mm | In distribution |
| 1211.2415S | Height 5 mm | In distribution |
| 1211.5809S | Height 9 mm | In distribution |
| 1211.5842S | Width 18 mm | In distribution |
| 1211.5852S | Width 18 mm | In distribution |
| 1211.2426S | Depth 12 mm | In distribution |
| 1211.4648S | Height 8 mm | In distribution |
| 1406.2498S | In distribution | |
| 1213.8009S | Height 9 mm | In distribution |
| 1211.2436S | Height 6 mm | In distribution |
| 1211.4641S | Angle 15 ° | In distribution |
| 1211.5822S | Height 12 mm | In distribution |
| 1211.4615S | Width 16 mm | In distribution |
| 1211.5808S | Depth 15 mm | In distribution |
| 1211.4611S | Depth 14 mm | In distribution |
| 1211.5830S | Height 10 mm | In distribution |
| 1211.2405S | Width 14 mm | In distribution |
| 1406.5881S | In distribution | |
| 1211.2430S | Height 10 mm | In distribution |
| 1211.2429S | Height 9 mm | In distribution |
| 1406.2406S | In distribution | |
| 1213.4005S | Depth 8 mm | In distribution |
| 1211.5812S | Depth 15 mm | In distribution |
| 1213.8077S | Height 7 mm | In distribution |
| 1211.4605S | Width 16 mm | In distribution |
| 1406.2409S | In distribution | |
| 1211.4639S | Angle 15 ° | In distribution |
| 1211.5818S | Angle 7 ° | In distribution |
| 1211.4619S | Width 16 mm | In distribution |
| 1211.5838S | Angle 15 ° | In distribution |
| 1211.4632S | Height 12 mm | In distribution |
| 1213.4006S | Width 14 mm | In distribution |
| 1211.2406S | Height 6 mm | In distribution |
| 1211.2410S | Height 10 mm | In distribution |
| 1211.5805S | Height 5 mm | In distribution |
| 1211.2417S | Angle 7 ° | In distribution |
| 1213.6087S | Height 7 mm | In distribution |
| 1211.2421S | Width 14 mm | In distribution |
| 1211.2432S | Angle 12 ° | In distribution |
| 1211.5832S | Depth 15 mm | In distribution |
| 1211.4627S | Width 16 mm | In distribution |
| 1406.4696S | In distribution | |
| 1406.5880S | In distribution | |
| 1211.5828S | Width 18 mm | In distribution |
| 1406.4698S | In distribution | |
| 1211.4606S | Width 16 mm | In distribution |
| 1406.4675S | In distribution | |
| 1406.5882S | In distribution | |
| 1406.2499S | In distribution | |
| 1213.8007S | Height 7 mm | In distribution |
| 1211.2428S | Depth 12 mm | In distribution |
| 1211.5849S | Height 9 mm | In distribution |
| 1211.4628S | Width 16 mm | In distribution |
| 1213.6006S | Height 6 mm | In distribution |
| 1211.5821S | Width 18 mm | In distribution |
| 1213.4087S | Height 7 mm | In distribution |
| 1406.5812S | In distribution | |
| 1406.4609S | In distribution | |
| 1211.4640S | Depth 14 mm | In distribution |
| 1213.4082S | Depth 8 mm | In distribution |
| 1211.2407S | Depth 12 mm | In distribution |
| 1211.5806S | Height 6 mm | In distribution |
| 1211.5829S | Depth 15 mm | In distribution |
| 1213.4080S | Width 14 mm | In distribution |
| 1406.5897S | In distribution | |
| 1213.8090S | Depth 10.5 mm | In distribution |
| 1406.4606S | In distribution | |
| 1211.5810S | Height 10 mm | In distribution |
| 1213.8089S | Height 9 mm | In distribution |
| 1211.4617S | Depth 14 mm | In distribution |
| 1406.4699S | In distribution | |
| 1213.4081S | Depth 8 mm | In distribution |
| 1406.2502S | In distribution | |
| 1211.4626S | Depth 14 mm | In distribution |
| 1211.4652S | Angle 20 ° | In distribution |
| 1211.5816S | Angle 7 ° | In distribution |
| 1211.5839S | Height 9 mm | In distribution |
| 1211.5826S | Angle 12 ° | In distribution |
| 1406.2480S | In distribution | |
| 1213.6089S | Height 9 mm | In distribution |
| 1406.5876S | In distribution | |
| 1211.4650S | Width 16 mm | In distribution |
| 1406.5807S | In distribution | |
| 1211.4622S | Depth 14 mm | In distribution |
| 1213.6079S | Height 9 mm | In distribution |
| 1211.2449S | Width 14 mm | In distribution |
| 1211.2448S | Depth 12 mm | In distribution |
| 1213.8011S | Width 18 mm | In distribution |
| 1211.2416S | Depth 12 mm | In distribution |
| 1213.8012S | Height 12 mm | In distribution |
| 1211.4651S | Angle 20 ° | In distribution |
| 1213.8082S | Width 18 mm | In distribution |
| 1213.6085S | Depth 10 mm | In distribution |
| 1213.8079S | Angle 7 ° | In distribution |
| 1213.8006S | Height 6 mm | In distribution |
| 1406.5809S | In distribution | |
| 1213.8092S | Width 18 mm | In distribution |
| 1211.4618S | Depth 14 mm | In distribution |
| 1213.8085S | Depth 10.5 mm | In distribution |
| 1211.2447S | Angle 20 ° | In distribution |
| 1211.2450S | Angle 20 ° | In distribution |
| 1211.2427S | Height 7 mm | In distribution |
| 1211.5819S | Width 18 mm | In distribution |
| 1211.4638S | Depth 14 mm | In distribution |
| 1211.4637S | Angle 15 ° | In distribution |
| 1211.5807S | Width 18 mm | In distribution |
| 1213.6008S | Width 16 mm | In distribution |
| 1211.2422S | Width 14 mm | In distribution |
| 1406.5877S | In distribution | |
| 1211.4649S | Angle 20 ° | In distribution |
| 1213.4089S | Angle 12 ° | In distribution |
| 1406.2500S | In distribution | |
| 1211.5817S | Height 7 mm | In distribution |
| 1211.2408S | Depth 12 mm | In distribution |
| 1213.4079S | Depth 8 mm | In distribution |
| 1406.4681S | In distribution | |
| 1406.4702S | In distribution | |
| 1406.4700S | In distribution | |
| 1211.5831S | Height 11 mm | In distribution |
| 1213.6012S | Width 16 mm | In distribution |
| 1211.2438S | Height 8 mm | In distribution |
| 1211.5827S | Angle 12 ° | In distribution |
| 1213.4076S | Width 14 mm | In distribution |
| 1211.2411S | Height 11 mm | In distribution |
| 1211.5840S | Depth 15 mm | In distribution |
| 1211.2441S | Height 11 mm | In distribution |
| 1406.2501S | In distribution | |
| 1211.5837S | Angle 15 ° | In distribution |
| 1211.2419S | Height 9 mm | In distribution |
| 1213.4086S | Width 14 mm | In distribution |
| 1211.5815S | Width 18 mm | In distribution |
| 1211.4609S | Depth 14 mm | In distribution |
| 1406.5902S | In distribution | |
| 1211.2412S | Width 14 mm | In distribution |
| 1211.5850S | Depth 15 mm | In distribution |
| 1213.6081S | Width 16 mm | In distribution |
| 1211.5848S | Width 18 mm | In distribution |
| 1211.4642S | Width 16 mm | In distribution |
| 1213.8088S | Width 18 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.