E3D-A Interbody System
E3D-A is an anterior interbody fusion system with titanium alloy cages in static and integrated designs. The cages provide structural stability during spinal fusion, with different sizes to…
E3D-A is an anterior interbody fusion system with titanium alloy cages in static and integrated designs. The cages provide structural stability during spinal fusion, with different sizes to accommodate anatomical requirements.
The cage bodies are additively manufactured. Integrated versions use three titanium alloy screws for fixation, while the static and integrated bodies remain distinct configurations within the system.
Listed Item
HAnano STATIC Ti ALIF 32 X 24mm 20deg 18mm (P 10mm)
Surface Options
Implants are available with or without HAnano Surface, a hydroxyapatite treatment 20 to 40 nanometers thick. This adds nanoscale topography across the implant surface, providing a separate surface option alongside the choice of cage size and fixation design.
3manufacturers in China registered for this device type
186catalogue numbers in this listing
3510(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 | Evolution Spine, LLC, 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 | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K232432 |
| Record published | 2024-02-13 |
| Record revised | 2024-09-11 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Angle 8 to 30 °; depth 24 to 28 mm; height 10 to 29 mm; width 32 to 40 mm; outer diameter 5.5 to 6 mm; length 20 to 40 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 110H-L2018 | Angle 20 ° | In distribution |
| 110H-S1512 | Depth 24 mm | In distribution |
| 111H-ML1512 | Height 12 mm | In distribution |
| 110H-S0817 | Depth 24 mm | In distribution |
| 111H-L2521 | Width 40 mm | In distribution |
| 110G-S0813 | Height 13 mm | In distribution |
| 111H-L2013 | Depth 28 mm | In distribution |
| 110G-L3018 | Width 40 mm | In distribution |
| 111H-L0810 | Width 40 mm | In distribution |
| 110G-S0819 | Depth 24 mm | In distribution |
| 110H-S2014 | Height 14 mm | In distribution |
| 111H-M2517 | Height 17 mm | In distribution |
| 111H-S2016 | Angle 20 ° | In distribution |
| 110G-L0815 | Angle 8 ° | In distribution |
| 110G-M1514 | Height 14 mm | In distribution |
| 110H-60FT30 | In distribution | |
| 111H-L0811 | Depth 28 mm | In distribution |
| 110H-ML3020 | Height 20 mm | In distribution |
| 111H-M1512 | Depth 26 mm | In distribution |
| 110H-ML1514 | Depth 28 mm | In distribution |
| 111H-M0815 | Angle 8 ° | In distribution |
| 110H-60FB40-3 | In distribution | |
| 111H-S2018 | Angle 20 ° | In distribution |
| 110G-L1517 | Depth 28 mm | In distribution |
| 111H-L2519 | Depth 28 mm | In distribution |
| 111H-ML1521 | Depth 28 mm | In distribution |
| 111H-L0816 | Angle 8 ° | In distribution |
| 110H-L0814 | Angle 8 ° | In distribution |
| 110G-S2519 | Height 19 mm | In distribution |
| 110H-L0811 | Height 11 mm | In distribution |
| 110G-ML2014 | Angle 20 ° | In distribution |
| 110H-L0819 | Width 40 mm | In distribution |
| 110H-L2516 | Angle 25 ° | In distribution |
| 110G-L2019 | Depth 28 mm | In distribution |
| 110G-S3020 | Depth 24 mm | In distribution |
| 110H-L1513 | Height 13 mm | In distribution |
| 110-60FT20 | Outer Diameter 6 mm | In distribution |
| 111H-ML2018 | Width 38 mm | In distribution |
| 111H-ML0820 | Depth 28 mm | In distribution |
| 110H-M0818 | Width 36 mm | In distribution |
| 111H-L2520 | Angle 25 ° | In distribution |
| 110H-60FT20-2 | In distribution | |
| 110H-ML0818 | Width 38 mm | In distribution |
| 111H-M2020 | Height 20 mm | In distribution |
| 111H-L1516 | Width 40 mm | In distribution |
| 110H-M2015 | Width 36 mm | In distribution |
| 111H-M2519 | Height 19 mm | In distribution |
| 110H-S2018 | Depth 24 mm | In distribution |
| 110G-S0820 | Width 32 mm | In distribution |
| 110G-S2019 | Width 32 mm | In distribution |
| 110-60FB35 | Length 35 mm | In distribution |
| 110H-M1521 | Depth 26 mm | In distribution |
| 110G-ML0813 | Height 13 mm | In distribution |
| 110H-60FT40 | In distribution | |
| 111H-M2015 | Depth 26 mm | In distribution |
| 110H-ML1515 | Depth 28 mm | In distribution |
| 110H-M0813 | Depth 26 mm | In distribution |
| 110G-L0821 | Depth 28 mm | In distribution |
| 110H-M2515 | Depth 26 mm | In distribution |
| 110G-L3019 | Height 19 mm | In distribution |
| 111H-M0819 | Depth 26 mm | In distribution |
| 110H-L2517 | Depth 28 mm | In distribution |
| 110G-L2021 | Angle 20 ° | In distribution |
| 110H-S1519 | Height 19 mm | In distribution |
| 110G-S1513 | Angle 15 ° | In distribution |
| 110G-S3021 | Width 32 mm | In distribution |
| 110H-L3017 | Height 17 mm | In distribution |
| 110G-ML2517 | Depth 28 mm | In distribution |
| 110H-60FB30 | In distribution | |
| 110H-55VB40 | In distribution | |
| 111H-M0814 | Depth 26 mm | In distribution |
| 110G-ML1517 | Angle 15 ° | In distribution |
| 111H-S0814 | Angle 8 ° | In distribution |
| 110H-S2516 | Depth 24 mm | In distribution |
| 110H-55VB20 | In distribution | |
| 110G-L2016 | Width 40 mm | In distribution |
| 110G-L1511 | Height 11 mm | In distribution |
| 110H-55VT40-2 | In distribution | |
| 110G-L3017 | Depth 28 mm | In distribution |
| 111H-M0820 | Width 36 mm | In distribution |
| 110H-L2020 | Width 40 mm | In distribution |
| 111H-L0817 | Depth 28 mm | In distribution |
| 110G-L2018 | Width 40 mm | In distribution |
| 111H-L0819 | Height 19 mm | In distribution |
| 111H-S2017 | Angle 20 ° | In distribution |
| 110G-M1519 | Height 19 mm | In distribution |
| 110-55VT20 | Length 20 mm | In distribution |
| 111H-ML1516 | Angle 15 ° | In distribution |
| 111H-ML0809 | Width 38 mm | In distribution |
| 110H-L0820 | Angle 8 ° | In distribution |
| 111H-ML0812 | Depth 28 mm | In distribution |
| 110G-L0816 | Height 16 mm | In distribution |
| 110H-ML1519 | Depth 28 mm | In distribution |
| 110H-55VT20-3 | In distribution | |
| 110H-S2518 | Angle 25 ° | In distribution |
| 111H-ML1518 | Width 38 mm | In distribution |
| 110H-ML2517 | Depth 28 mm | In distribution |
| 110G-S0818 | Width 32 mm | In distribution |
| 110G-M0816 | Height 16 mm | In distribution |
| 110H-ML2520 | Depth 28 mm | In distribution |
| 111H-ML2518 | Height 18 mm | In distribution |
| 111H-S3018 | Height 18 mm | In distribution |
| 111H-S2020 | Height 20 mm | In distribution |
| 111H-M0821 | Angle 8 ° | In distribution |
| 110H-S3020 | Depth 24 mm | In distribution |
| 110H-S3019 | Angle 30 ° | In distribution |
| 110G-L1513 | Height 13 mm | In distribution |
| 111H-S2520 | Depth 24 mm | In distribution |
| 110H-S2013 | Width 32 mm | In distribution |
| 110H-M2517 | Width 36 mm | In distribution |
| 111H-M1511 | Height 11 mm | In distribution |
| 110G-M0820 | Depth 26 mm | In distribution |
| 111H-S3017 | Angle 30 ° | In distribution |
| 111H-L3020 | Angle 30 ° | In distribution |
| 111H-M3021 | Width 36 mm | In distribution |
| 110G-M2019 | Width 36 mm | In distribution |
| 110-55VB40 | Length 40 mm | In distribution |
| 110H-ML2016 | Width 38 mm | In distribution |
| 110G-S2013 | Width 32 mm | In distribution |
| 111H-ML2014 | Depth 28 mm | In distribution |
| 110H-S0821 | Width 32 mm | In distribution |
| 110-55VB25 | Length 25 mm | In distribution |
| 111H-S3021 | Depth 24 mm | In distribution |
| 111H-ML0821 | Width 38 mm | In distribution |
| 110H-L2016 | Angle 20 ° | In distribution |
| 110H-L2515 | Depth 28 mm | In distribution |
| 110H-M0820 | Angle 8 ° | In distribution |
| 110H-M2518 | Width 36 mm | In distribution |
| 110H-55VT35 | In distribution | |
| 111H-ML2517 | Width 38 mm | In distribution |
| 110H-L2019 | Width 40 mm | In distribution |
| 110G-S2517 | Width 32 mm | In distribution |
| 110G-M3021 | Width 36 mm | In distribution |
| 110H-S3018 | Angle 30 ° | In distribution |
| 111H-S2515 | Width 32 mm | In distribution |
| 110H-55VB35-2 | In distribution | |
| 110H-L0815 | Depth 28 mm | In distribution |
| 111H-L1514 | Angle 15 ° | In distribution |
| 110G-M2020 | Angle 20 ° | In distribution |
| 110-55VT40 | Length 40 mm | In distribution |
| 110-A066 | In distribution | |
| 110G-S1516 | Height 16 mm | In distribution |
| 110H-L2014 | Angle 20 ° | In distribution |
| 110H-S1520 | Depth 24 mm | In distribution |
| 110G-M0811 | Width 36 mm | In distribution |
| 110H-55VB25-2 | In distribution | |
| 111H-S2519 | Depth 24 mm | In distribution |
| 110H-M0816 | Angle 8 ° | In distribution |
| 110G-M1511 | Height 11 mm | In distribution |
| 110G-L2015 | Depth 28 mm | In distribution |
| 111H-S0815 | Height 15 mm | In distribution |
| 110G-ML1515 | Depth 28 mm | In distribution |
| 110-55VB35 | Length 35 mm | In distribution |
| 110G-S1519 | Depth 24 mm | In distribution |
| 110H-M1517 | Angle 15 ° | In distribution |
| 111H-L2518 | Depth 28 mm | In distribution |
| 110H-L1518 | Depth 28 mm | In distribution |
| 110H-55VT30-2 | In distribution | |
| 110H-60FB35 | In distribution | |
| 110H-L3018 | Angle 30 ° | In distribution |
| 111H-ML2013 | Angle 20 ° | In distribution |
| 110H-55VB35-3 | In distribution | |
| 110H-S2019 | Depth 24 mm | In distribution |
| 111H-M3018 | Height 18 mm | In distribution |
| 110G-L2517 | Height 17 mm | In distribution |
| 110H-M0819 | Width 36 mm | In distribution |
| 110-55VB30 | Outer Diameter 5.5 mm | In distribution |
| 110G-L0814 | Angle 8 ° | In distribution |
| 110G-M2517 | Width 36 mm | In distribution |
| 111H-M0812 | Depth 26 mm | In distribution |
| 110G-ML3020 | Width 38 mm | In distribution |
| 110H-S2519 | Depth 24 mm | In distribution |
| 111H-L2019 | Depth 28 mm | In distribution |
| 110G-L3020 | Width 40 mm | In distribution |
| 110G-M2021 | Width 36 mm | In distribution |
| 110H-M2014 | Height 14 mm | In distribution |
| 111H-S1516 | Depth 24 mm | In distribution |
| 111H-L2016 | Angle 20 ° | In distribution |
| 110H-60FB40-2 | In distribution | |
| 110H-M2016 | Depth 26 mm | In distribution |
| 110G-S1521 | Depth 24 mm | In distribution |
| 110H-55VT35-3 | In distribution | |
| 110G-M1513 | Height 13 mm | In distribution |
| 111H-ML1520 | Depth 28 mm | In distribution |
| 110H-S1518 | Depth 24 mm | In distribution |
| 111H-ML2020 | Height 20 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 |
|---|---|
| K240368 | 2024-05-15 |
| K232432 | 2024-01-30 |
| K223146 | 2023-02-07 |
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.