Hedron
Locking Bone Screw, Self-Drilling 5.5mm, 40mm
3manufacturers in China registered for this device type
29catalogue numbers in this listing
11510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shandong (2), Jiangsu (1). 2 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 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Globus Medical, Inc., United States |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K191391 |
| Record published | 2019-12-27 |
| Record revised | 2025-07-14 (version 3) |
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, expiry date |
| Sizes | Height 11 to 23 mm; angle 8 to 30 °; depth 24 to 29 mm; width 30 to 39 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1212.0921S | Height 21 mm | In distribution |
| 7212.1040 | In distribution | |
| 1212.1523S | Depth 29 mm | In distribution |
| 7212.0035 | In distribution | |
| 1212.1415S | Angle 25 ° | In distribution |
| 1212.0113S | Depth 24 mm | In distribution |
| 7212.1025 | In distribution | |
| 1212.0813S | Depth 26 mm | In distribution |
| 1212.0217S | Angle 15 ° | In distribution |
| 1212.0619S | Depth 26 mm | In distribution |
| 1212.1319S | Depth 29 mm | In distribution |
| 1212.0517S | Angle 30 ° | In distribution |
| 1212.1219S | Depth 29 mm | In distribution |
| 1212.1521S | Depth 29 mm | In distribution |
| 1212.1019S | Angle 30 ° | In distribution |
| 1212.0915S | Height 15 mm | In distribution |
| 1212.0419S | Width 30 mm | In distribution |
| 1212.1017S | Width 34 mm | In distribution |
| 1212.1519S | Height 19 mm | In distribution |
| 1212.0313S | Width 30 mm | In distribution |
| 1212.0519S | Height 19 mm | In distribution |
| 1212.1215S | Height 15 mm | In distribution |
| 1212.0115S | Depth 24 mm | In distribution |
| 1212.0611S | Width 34 mm | In distribution |
| 1212.1417S | Height 17 mm | In distribution |
| 1212.0213S | Width 30 mm | In distribution |
| 1212.0615S | Angle 8 ° | In distribution |
| 1212.1317S | Angle 20 ° | In distribution |
| 1212.0211S | Depth 24 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sirion | Astura Medical | 1,465 |
| IdentiTi | Alphatec Spine, Inc. | 1,372 |
| EL Capitan | Astura Medical | 1,205 |
| Zavation | Zavation | 1,157 |
| Brigade | Nuvasive, Inc. | 1,005 |
| Solar™ Interbody Fusion System | Degen Medical | 899 |
| Zavation F3D Corpectomy | Zavation | 730 |
| ROI-A | Ldr Spine USA | 552 |
| Avenue L | Ldr Spine USA | 524 |
| Transcend Nanotec | Alphatec Spine, Inc. | 485 |
| Endoskeleton® TL Hyperlordotic nanoLOCK® Surface Technology | Titan Spine, LLC | 462 |
| Base | Nuvasive, Inc. | 462 |
Showing 12 of 241. All products under Intervertebral Fusion Device With Integrated Fixation, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253401 | 2026-04-29 |
| K201087 | 2020-07-31 |
| K170157 | 2017-09-25 |
| K161379 | 2016-09-29 |
| K160597 | 2016-08-29 |
| K161223 | 2016-07-15 |
| K142498 | 2015-02-26 |
| K132559 | 2013-12-30 |
| K120101 | 2012-03-27 |
| K103382 | 2011-05-20 |
| K082252 | 2008-11-05 |
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.