E3D-A Interbody System
HAnano STATIC Ti ALIF 40 X 28mm 15deg 18mm (P 10mm)
14manufacturers in China registered for this device type
292catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (6), Shandong (2), Shanghai (2). 7 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Showing 12 of 14. All 14 manufacturers in China registered for Intervertebral Fusion Device With Bone Graft, Lumbar
Record
| Listed by | Evolution Spine, LLC, United States |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, 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 | Height 9 to 21 mm; angle 8 to 30 °; depth 24 to 28 mm; width 32 to 40 mm; outer diameter 5.5 to 6 mm; length 25 to 40 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 111H-L2018 | Height 18 mm | In distribution |
| 110G-L2518 | Width 40 mm | In distribution |
| 110H-M3020 | Height 20 mm | In distribution |
| 111H-ML0811 | Height 11 mm | In distribution |
| 111H-S0821 | Angle 8 ° | In distribution |
| 110G-S2516 | Depth 24 mm | In distribution |
| 111G-S0814 | Width 32 mm | In distribution |
| 110G-ML1513 | Height 13 mm | In distribution |
| 110G-M0815 | Angle 8 ° | In distribution |
| 110G-S2520 | Angle 25 ° | In distribution |
| 111H-L1518 | Depth 28 mm | In distribution |
| 110G-M2515 | Angle 25 ° | In distribution |
| 110H-ML3019 | Angle 30 ° | In distribution |
| 110H-L0817 | Angle 8 ° | In distribution |
| 110H-60FT30-2 | In distribution | |
| 110-60FT30 | Outer Diameter 6 mm | In distribution |
| 111G-S2518 | Height 18 mm | In distribution |
| 111G-M2020 | Angle 20 ° | In distribution |
| 110G-ML1521 | Angle 15 ° | In distribution |
| 111G-ML2015 | Depth 28 mm | In distribution |
| 110G-ML2521 | Width 38 mm | In distribution |
| 110G-L0818 | Width 40 mm | In distribution |
| 110H-ML3021 | Depth 28 mm | In distribution |
| 111G-ML0816 | Angle 8 ° | In distribution |
| 110H-L0812 | Depth 28 mm | In distribution |
| 111G-S0819 | Angle 8 ° | In distribution |
| 111G-ML1518 | Height 18 mm | In distribution |
| 111G-M2518 | Height 18 mm | In distribution |
| 111G-L0820 | Height 20 mm | In distribution |
| 111G-M2517 | Height 17 mm | In distribution |
| 110H-ML2020 | Width 38 mm | In distribution |
| 110H-ML0813 | Angle 8 ° | In distribution |
| 110G-L0813 | Angle 8 ° | In distribution |
| 110H-L3021 | Height 21 mm | In distribution |
| 110H-M0814 | Height 14 mm | In distribution |
| 110H-L2013 | Width 40 mm | In distribution |
| 111G-ML0809 | Depth 28 mm | In distribution |
| 111G-ML1517 | Depth 28 mm | In distribution |
| 111H-ML1515 | Angle 15 ° | In distribution |
| 110H-M3017 | Depth 26 mm | In distribution |
| 111G-M1511 | Width 36 mm | In distribution |
| 111G-L1520 | Height 20 mm | In distribution |
| 110G-S1512 | Height 12 mm | In distribution |
| 111H-L2014 | Angle 20 ° | In distribution |
| 111G-S0817 | Depth 24 mm | In distribution |
| 111H-ML2516 | Angle 25 ° | In distribution |
| 111H-M1517 | Depth 26 mm | In distribution |
| 111G-ML2016 | Height 16 mm | In distribution |
| 111G-M2014 | Depth 26 mm | In distribution |
| 110H-60FT40-2 | In distribution | |
| 110H-60FT35 | In distribution | |
| 111H-S1517 | Depth 24 mm | In distribution |
| 110H-L1521 | Depth 28 mm | In distribution |
| 111G-M2516 | Width 36 mm | In distribution |
| 110H-S2517 | Angle 25 ° | In distribution |
| 111G-L1514 | Depth 28 mm | In distribution |
| 110G-M0818 | Depth 26 mm | In distribution |
| 110G-L2013 | Angle 20 ° | In distribution |
| 111G-S3019 | Height 19 mm | In distribution |
| 111G-L1513 | Depth 28 mm | In distribution |
| 110H-L3020 | Height 20 mm | In distribution |
| 110H-S0819 | Height 19 mm | In distribution |
| 111G-ML2515 | Angle 25 ° | In distribution |
| 110H-60FT35-3 | In distribution | |
| 110H-M3021 | Height 21 mm | In distribution |
| 110G-M0814 | Width 36 mm | In distribution |
| 111H-ML3020 | Angle 30 ° | In distribution |
| 111H-ML2521 | Depth 28 mm | In distribution |
| 111G-S0809 | Height 9 mm | In distribution |
| 111G-ML3020 | Width 38 mm | In distribution |
| 110H-M2020 | Depth 26 mm | In distribution |
| 110G-S2018 | Height 18 mm | In distribution |
| 111G-L1518 | Angle 15 ° | In distribution |
| 111H-S2517 | Angle 25 ° | In distribution |
| 110G-M0812 | Angle 8 ° | In distribution |
| 110G-S1514 | Angle 15 ° | In distribution |
| 111H-S1513 | Width 32 mm | In distribution |
| 111H-ML0819 | Height 19 mm | In distribution |
| 111H-S0809 | Angle 8 ° | In distribution |
| 111G-L3018 | Angle 30 ° | In distribution |
| 110H-L0816 | Height 16 mm | In distribution |
| 111G-M2018 | Height 18 mm | In distribution |
| 110H-60FB30-3 | In distribution | |
| 111G-L1517 | Angle 15 ° | In distribution |
| 110H-60FT25-3 | In distribution | |
| 110H-S2015 | Height 15 mm | In distribution |
| 111G-L0810 | Width 40 mm | In distribution |
| 110H-60FB40 | In distribution | |
| 110H-55VB40-2 | In distribution | |
| 111G-M0813 | Height 13 mm | In distribution |
| 111G-S2016 | Height 16 mm | In distribution |
| 111H-ML2019 | Height 19 mm | In distribution |
| 111H-M3020 | Depth 26 mm | In distribution |
| 111G-L2521 | Height 21 mm | In distribution |
| 111H-M0809 | Depth 26 mm | In distribution |
| 111H-M2516 | Height 16 mm | In distribution |
| 111G-S2520 | Depth 24 mm | In distribution |
| 111G-M1520 | Angle 15 ° | In distribution |
| 110G-L2521 | Depth 28 mm | In distribution |
| 111H-S0818 | Depth 24 mm | In distribution |
| 111G-ML3021 | Depth 28 mm | In distribution |
| 110H-L2521 | Depth 28 mm | In distribution |
| 110G-M2017 | Depth 26 mm | In distribution |
| 110G-ML2020 | Depth 28 mm | In distribution |
| 111G-L0813 | Width 40 mm | In distribution |
| 110G-ML0815 | Width 38 mm | In distribution |
| 110H-ML0815 | Height 15 mm | In distribution |
| 111H-S2019 | Width 32 mm | In distribution |
| 111G-S2017 | Height 17 mm | In distribution |
| 110G-L1520 | Width 40 mm | In distribution |
| 110G-S2015 | Angle 20 ° | In distribution |
| 111H-M0816 | Angle 8 ° | In distribution |
| 111G-L2014 | Angle 20 ° | In distribution |
| 111H-L2515 | Angle 25 ° | In distribution |
| 111H-S1518 | Height 18 mm | In distribution |
| 110H-M3019 | Width 36 mm | In distribution |
| 111G-ML2019 | Angle 20 ° | In distribution |
| 111H-S1512 | Angle 15 ° | In distribution |
| 111H-M2520 | Width 36 mm | In distribution |
| 110H-L3019 | Height 19 mm | In distribution |
| 111G-L2516 | Width 40 mm | In distribution |
| 111G-ML2517 | Depth 28 mm | In distribution |
| 111H-ML2017 | Depth 28 mm | In distribution |
| 110G-L1514 | Height 14 mm | In distribution |
| 111G-ML0813 | Width 38 mm | In distribution |
| 111H-L2516 | Height 16 mm | In distribution |
| 110H-S2017 | Height 17 mm | In distribution |
| 111H-L1513 | Depth 28 mm | In distribution |
| 110G-ML1514 | Width 38 mm | In distribution |
| 110H-60FB30-2 | In distribution | |
| 111H-L0813 | Angle 8 ° | In distribution |
| 111H-M3019 | Angle 30 ° | In distribution |
| 111G-M0819 | Depth 26 mm | In distribution |
| 110-60FT40 | Outer Diameter 6 mm | In distribution |
| 111H-L1519 | Angle 15 ° | In distribution |
| 111H-ML1511 | Depth 28 mm | In distribution |
| 110H-M2018 | Angle 20 ° | In distribution |
| 110G-ML2021 | Angle 20 ° | In distribution |
| 111G-M2015 | Height 15 mm | In distribution |
| 111H-ML1513 | Depth 28 mm | In distribution |
| 110-55VT25 | Length 25 mm | In distribution |
| 110H-ML2516 | Height 16 mm | In distribution |
| 111G-S2019 | Height 19 mm | In distribution |
| 111H-S3019 | Depth 24 mm | In distribution |
| 111G-M2019 | Height 19 mm | In distribution |
| 111G-ML0815 | Depth 28 mm | In distribution |
| 110H-ML2521 | Width 38 mm | In distribution |
| 110H-S0816 | Height 16 mm | In distribution |
| 110H-60FT20 | In distribution | |
| 111H-M0810 | Width 36 mm | In distribution |
| 111G-L0815 | Width 40 mm | In distribution |
| 110-55VT35 | Length 35 mm | In distribution |
| 110G-ML3019 | Angle 30 ° | In distribution |
| 111G-ML2018 | Height 18 mm | In distribution |
| 110G-L0811 | Width 40 mm | In distribution |
| 110H-55VT30 | In distribution | |
| 111G-M0815 | Width 36 mm | In distribution |
| 110-60FB40 | Outer Diameter 6 mm | In distribution |
| 110G-M0817 | Angle 8 ° | In distribution |
| 110H-M3018 | Width 36 mm | In distribution |
| 111H-S0819 | Height 19 mm | In distribution |
| 110H-M1515 | Angle 15 ° | In distribution |
| 110G-L0820 | Angle 8 ° | In distribution |
| 111H-M1515 | Depth 26 mm | In distribution |
| 111G-S0821 | Width 32 mm | In distribution |
| 111G-M1512 | Depth 26 mm | In distribution |
| 110G-ML2518 | Width 38 mm | In distribution |
| 110H-ML2018 | Height 18 mm | In distribution |
| 110H-ML1521 | Height 21 mm | In distribution |
| 110H-M2516 | Height 16 mm | In distribution |
| 111G-L2016 | Depth 28 mm | In distribution |
| 111G-M3018 | Angle 30 ° | In distribution |
| 110G-L2519 | Angle 25 ° | In distribution |
| 111H-M1520 | Height 20 mm | In distribution |
| 111G-ML1511 | Width 38 mm | In distribution |
| 111G-M0821 | Angle 8 ° | In distribution |
| 110H-ML2017 | Depth 28 mm | In distribution |
| 111G-S2519 | Width 32 mm | In distribution |
| 110H-M1513 | Height 13 mm | In distribution |
| 111G-M1519 | Angle 15 ° | In distribution |
| 111G-ML2521 | Angle 25 ° | In distribution |
| 110H-L0818 | Width 40 mm | In distribution |
| 110H-L1517 | Depth 28 mm | In distribution |
| 111G-L1519 | Depth 28 mm | In distribution |
| 111G-S1520 | Width 32 mm | In distribution |
| 111G-S1521 | Height 21 mm | In distribution |
| 111G-M1521 | Width 36 mm | In distribution |
| 110H-55VT40-3 | In distribution | |
| 111G-M1514 | Depth 26 mm | In distribution |
| 110H-55VB35 | In distribution | |
| 110H-S2020 | Width 32 mm | In distribution |
| 110H-60FT25 | In distribution | |
| 110H-S1513 | Angle 15 ° | In distribution |
| 110H-S2520 | Width 32 mm | In distribution |
| 110H-M2017 | Angle 20 ° | In distribution |
| 110H-ML3018 | Depth 28 mm | In distribution |
| 111G-S2515 | Angle 25 ° | In distribution |
| 110G-ML2018 | Depth 28 mm | In distribution |
| 110H-ML1511 | Height 11 mm | In distribution |
| 111G-S2517 | Width 32 mm | In distribution |
| 111G-M3021 | Angle 30 ° | In distribution |
| 110G-ML0821 | Angle 8 ° | In distribution |
| 111G-ML2519 | Height 19 mm | In distribution |
| 111G-L1512 | Depth 28 mm | In distribution |
| 111G-L0818 | Depth 28 mm | In distribution |
| 111H-L2517 | Angle 25 ° | In distribution |
| 111H-M3017 | Depth 26 mm | In distribution |
| 111H-S2015 | Depth 24 mm | In distribution |
| 111H-S0813 | Width 32 mm | In distribution |
| 110-60FB25 | Length 25 mm | In distribution |
| 110G-ML0812 | Depth 28 mm | In distribution |
| 111G-ML1520 | Angle 15 ° | In distribution |
| 111G-L1521 | Depth 28 mm | In distribution |
| 110H-M0817 | Width 36 mm | In distribution |
| 110G-S0811 | Depth 24 mm | In distribution |
| 111H-ML1514 | Width 38 mm | In distribution |
| 111G-L3019 | Depth 28 mm | In distribution |
| 110G-S1511 | Depth 24 mm | In distribution |
| 110H-L1520 | Depth 28 mm | In distribution |
| 111H-ML1517 | Depth 28 mm | In distribution |
| 110G-S2518 | Height 18 mm | In distribution |
| 110G-S0816 | Height 16 mm | In distribution |
| 111H-S2516 | Height 16 mm | In distribution |
| 111G-ML0810 | Depth 28 mm | In distribution |
| 110G-S1517 | Height 17 mm | In distribution |
| 110G-ML0816 | Depth 28 mm | In distribution |
| 111G-L3017 | Height 17 mm | In distribution |
| 110H-ML3017 | Angle 30 ° | In distribution |
| 110G-M0821 | Angle 8 ° | In distribution |
| 111G-S1516 | Depth 24 mm | In distribution |
| 111H-M2518 | Angle 25 ° | In distribution |
| 111G-ML0821 | Depth 28 mm | In distribution |
| 110H-ML0816 | Height 16 mm | In distribution |
| 111G-S0812 | Width 32 mm | In distribution |
| 111G-S1513 | Height 13 mm | In distribution |
| 110H-M0815 | Height 15 mm | In distribution |
| 110H-ML2519 | Height 19 mm | In distribution |
| 110H-L2015 | Height 15 mm | In distribution |
| 111H-M2013 | Angle 20 ° | In distribution |
| 110G-M2016 | Depth 26 mm | In distribution |
| 110H-S1517 | Width 32 mm | In distribution |
| 111H-L0818 | Depth 28 mm | In distribution |
| 110G-S0814 | Width 32 mm | In distribution |
| 111G-ML1514 | Height 14 mm | In distribution |
| 111H-L3017 | Angle 30 ° | In distribution |
| 111G-ML1515 | Angle 15 ° | In distribution |
| 110G-M0819 | Width 36 mm | In distribution |
| 110G-ML1511 | Depth 28 mm | In distribution |
| 111G-L0811 | Angle 8 ° | In distribution |
| 110H-60FB20-2 | In distribution |
Showing 250 of 292 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Peridot Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 10,850 |
| Yellowstone | Summit Spine | 6,654 |
| CoRoent | Nuvasive, Inc. | 5,690 |
| Zavation | Zavation | 2,554 |
| Anyplus II Spinal Fixation System | GS Medical Co., Ltd. | 2,533 |
| Talos® IBF | Meditech Spine, LLC | 2,163 |
| Peridot-PT Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 1,956 |
| TirboLOX-L Lumbar Ibfd | Captiva Spine, Inc. | 1,926 |
| Endoskeleton® TL | Titan Spine, LLC | 1,896 |
| Evos Lumbar Interbody System | Cutting Edge Spine | 1,871 |
| Epiphany | Pantheon Spinal LLC | 1,507 |
| LnK Lumbar Interbody Fusion Cage System | L&K Biomed Co., Ltd. | 1,506 |
Showing 12 of 1,958. All products under Intervertebral Fusion Device With Bone Graft, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K160663 | 2016-11-16 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P000028 | 2004-06-18 | AFFINITY ANTERIOR CERVICAL CAGE SYSTEM | Medtronic Sofamor Danek USA, Inc. |
| P970015 | 2003-09-10 | LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE | Sofamor Danek |
| P980048 | 2001-04-20 | BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM | Sulzer Spine-Tech |
| P950019 | 1999-03-19 | RAY THREADED FUSION CAGE (TFC) DEVICE WITH INSTRUMENTATION | Stryker Spine |
| P950002 | 1997-06-30 | BAK INTERBODY FUSION SYSTEM | Zimmer Spine, Inc. |
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.