VEO Lateral Interbody Fusion System
Veo,angled TRIAL,POLISHED,0 DEG,22X7.5
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 | Choice Spine, LP |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| 510(k) | K123997 |
| Record published | 2018-10-26 |
| Record revised | 2020-02-24 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Height 7.5 to 17 mm; width 17 to 22 mm; length 40 to 65 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| V070-121717P | In distribution | |
| 22-0475-05 | Height 7.5 mm | In distribution |
| 22-0469-17 | Length 60 mm | In distribution |
| 22-0466-30 | Width 22 mm | In distribution |
| V070-A2275P | In distribution | |
| VT10-65170609 | Length 65 mm | In distribution |
| V070-A1713P | In distribution | |
| 22-0467-26 | Height 17 mm | In distribution |
| 22-0466-25 | Width 22 mm | In distribution |
| V070-62208P | In distribution | |
| V070-01711P | In distribution | |
| VT10-65170611 | Width 17 mm | In distribution |
| VT10-45220608 | Length 45 mm | In distribution |
| 22-0489-02 | Width 17 mm | In distribution |
| 22-0467-22 | Length 55 mm | In distribution |
| VT10-45170615 | Length 45 mm | In distribution |
| 22-0466-10 | Height 11 mm | In distribution |
| 22-0467-25 | Length 40 mm | In distribution |
| 22-0469-29 | Width 17 mm | In distribution |
| 22-0469-19 | Width 17 mm | In distribution |
| 22-0466-06 | Width 22 mm | In distribution |
| 22-0469-27 | Height 17 mm | In distribution |
| 22-0469-04 | Length 55 mm | In distribution |
| V070-01715P | In distribution | |
| 22-0466-12 | Width 22 mm | In distribution |
| 22-0468-29 | Height 17 mm | In distribution |
| VT10-40170609 | Width 17 mm | In distribution |
| 22-0469-18 | Height 13 mm | In distribution |
| 22-0467-19 | Height 15 mm | In distribution |
| VT10-55170007 | Length 55 mm | In distribution |
| 22-0469-13 | Width 17 mm | In distribution |
| 22-0466-21 | Length 50 mm | In distribution |
| VT10-40170613 | Length 40 mm | In distribution |
| 22-0469-21 | Length 50 mm | In distribution |
| VT10-50170007 | Width 17 mm | In distribution |
| 22-0475-04 | Width 22 mm | In distribution |
| 22-0469-12 | Height 11 mm | In distribution |
| 22-0468-04 | Width 22 mm | In distribution |
| 22-0490-03 | Length 50 mm | In distribution |
| 22-0466-17 | Length 60 mm | In distribution |
| 22-0476-02 | Height 8 mm | In distribution |
| 22-0466-03 | Height 9 mm | In distribution |
| 22-0466-02 | Length 45 mm | In distribution |
| V070-122215P | In distribution | |
| VT10-65170617 | Height 17 mm | In distribution |
| 22-0466-11 | Height 11 mm | In distribution |
| 22-0490-06 | Length 65 mm | In distribution |
| VT10-40220608 | Length 40 mm | In distribution |
| 22-0468-13 | Width 22 mm | In distribution |
| VT10-40170007 | Width 17 mm | In distribution |
| 22-0467-07 | Width 17 mm | In distribution |
| 22-0467-27 | Height 17 mm | In distribution |
| VT10-40170611 | Length 40 mm | In distribution |
| V070-01709P | In distribution | |
| 22-0468-19 | Height 15 mm | In distribution |
| 22-0489-05 | Width 17 mm | In distribution |
| 22-0469-06 | Length 65 mm | In distribution |
| 22-0469-23 | Height 15 mm | In distribution |
| V070-121713P | In distribution | |
| V070-02213P | In distribution | |
| 22-0466-24 | Length 65 mm | In distribution |
| 22-0467-24 | Height 15 mm | In distribution |
| 22-0467-14 | Height 13 mm | In distribution |
| 22-0469-07 | Width 17 mm | In distribution |
| VT10-55170609 | Length 55 mm | In distribution |
| 22-0476-04 | Height 8 mm | In distribution |
| 22-0468-02 | Length 45 mm | In distribution |
| 22-0469-01 | Height 9 mm | In distribution |
| 22-0475-02 | Height 7.5 mm | In distribution |
| 22-0489-03 | Length 50 mm | In distribution |
| 22-0467-10 | Height 11 mm | In distribution |
| VT10-60170617 | Width 17 mm | In distribution |
| V070-121711P | In distribution | |
| 22-0466-16 | Length 55 mm | In distribution |
| 22-0476-05 | Height 8 mm | In distribution |
| 22-0468-16 | Length 55 mm | In distribution |
| 22-0490-01 | Height 8 mm | In distribution |
| 22-0469-15 | Width 17 mm | In distribution |
| 22-0468-15 | Height 13 mm | In distribution |
| 22-0466-18 | Width 22 mm | In distribution |
| VT10-45220007 | Length 45 mm | In distribution |
| 22-0467-17 | Width 17 mm | In distribution |
| 22-0468-18 | Width 22 mm | In distribution |
| 22-0468-12 | Height 11 mm | In distribution |
| V070-A2213P | In distribution | |
| V070-61711P | In distribution | |
| 22-0467-04 | Width 17 mm | In distribution |
| VT10-50220608 | Height 8 mm | In distribution |
| V070-A1709P | In distribution | |
| 22-0468-12 | Width 22 mm | In distribution |
| VT10-45170007 | Width 17 mm | In distribution |
| VT10-65220608 | Width 22 mm | In distribution |
| VT10-60220608 | Height 8 mm | In distribution |
| V070-61708P | In distribution | |
| 22-0466-15 | Height 13 mm | In distribution |
| 22-0468-25 | Width 22 mm | In distribution |
| V070-A1715P | In distribution | |
| VT10-65170007 | Width 17 mm | In distribution |
| 22-0469-11 | Width 17 mm | In distribution |
| 22-0476-01 | Length 40 mm | In distribution |
| 22-0468-05 | Width 22 mm | In distribution |
| 22-0467-23 | Height 15 mm | In distribution |
| V070-02209P | In distribution | |
| 22-0468-20 | Length 45 mm | In distribution |
| 22-0466-22 | Height 15 mm | In distribution |
| 22-0469-22 | Width 17 mm | In distribution |
| V070-62213P | In distribution | |
| 22-0467-15 | Height 13 mm | In distribution |
| V070-A1775P | In distribution | |
| VT10-50170608 | Width 17 mm | In distribution |
| 22-0490-05 | Width 17 mm | In distribution |
| 22-0466-14 | Width 22 mm | In distribution |
| VT10-60170613 | Width 17 mm | In distribution |
| 22-0468-28 | Length 55 mm | In distribution |
| 22-0468-09 | Width 22 mm | In distribution |
| VT10-60170615 | Length 60 mm | In distribution |
| VT10-60170007 | Length 60 mm | In distribution |
| 22-0489-04 | Length 55 mm | In distribution |
| VT10-50170615 | Width 17 mm | In distribution |
| 22-0468-24 | Length 65 mm | In distribution |
| 22-0466-09 | Width 22 mm | In distribution |
| V070-A2209P | In distribution | |
| V070-02211P | In distribution | |
| 22-0476-03 | Width 22 mm | In distribution |
| 22-0490-01 | Length 40 mm | In distribution |
| VT10-50170617 | Height 17 mm | In distribution |
| 22-0468-14 | Width 22 mm | In distribution |
| VT10-45170617 | Height 17 mm | In distribution |
| 22-0469-10 | Length 55 mm | In distribution |
| V070-02275P | In distribution | |
| 22-0469-08 | Height 11 mm | In distribution |
| 22-0466-28 | Width 22 mm | In distribution |
| 22-0467-08 | Length 45 mm | In distribution |
| 22-0469-24 | Width 17 mm | In distribution |
| 22-0467-02 | Length 45 mm | In distribution |
| VT10-60170611 | Length 60 mm | In distribution |
| VT10-45170611 | Height 11 mm | In distribution |
| VT10-45170608 | Width 17 mm | In distribution |
| 22-0467-05 | Length 60 mm | In distribution |
| 22-0466-07 | Length 40 mm | In distribution |
| VT10-50170611 | Width 17 mm | In distribution |
| VT10-55170617 | Width 17 mm | In distribution |
| VT10-40170608 | Width 17 mm | In distribution |
| VT10-55170615 | Width 17 mm | In distribution |
| VT10-55170608 | Height 8 mm | In distribution |
| 22-0475-06 | Length 65 mm | In distribution |
| 22-0468-07 | Width 22 mm | In distribution |
| 22-0467-16 | Width 17 mm | In distribution |
| 22-0467-01 | Length 40 mm | In distribution |
| VT10-65170608 | Height 8 mm | In distribution |
| VT10-60170609 | Width 17 mm | In distribution |
| VT10-40220007 | Width 22 mm | In distribution |
| VT10-45170609 | Length 45 mm | In distribution |
| 22-0467-13 | Width 17 mm | In distribution |
| 22-0469-05 | Width 17 mm | In distribution |
| 22-0467-06 | Height 9 mm | In distribution |
| VT10-55220007 | Length 55 mm | In distribution |
| 22-0468-06 | Width 22 mm | In distribution |
| 22-0475-01 | Width 22 mm | In distribution |
| 22-0467-11 | Length 60 mm | In distribution |
| 22-0468-23 | Length 60 mm | In distribution |
| 22-0466-01 | Width 22 mm | In distribution |
| 22-0469-20 | Width 17 mm | In distribution |
| 22-0468-26 | Width 22 mm | In distribution |
| 22-0467-18 | Height 13 mm | In distribution |
| 22-0490-02 | Width 17 mm | In distribution |
| VT10-65170615 | Width 17 mm | In distribution |
| 22-0468-11 | Width 22 mm | In distribution |
| 22-0469-16 | Length 55 mm | In distribution |
| 22-0468-10 | Length 55 mm | In distribution |
| V070-A1711P | In distribution | |
| V070-62211P | In distribution | |
| VT10-55220608 | Length 55 mm | In distribution |
| 22-0469-25 | Height 17 mm | In distribution |
| 22-0476-06 | Height 8 mm | In distribution |
| 22-0468-01 | Length 40 mm | In distribution |
| VT10-50170609 | Height 9 mm | In distribution |
| 22-0489-01 | Length 40 mm | In distribution |
| 22-0467-29 | Width 17 mm | In distribution |
| 22-0469-03 | Height 9 mm | In distribution |
| V070-122213P | In distribution | |
| 22-0466-29 | Width 22 mm | In distribution |
| 22-0466-23 | Length 60 mm | In distribution |
| VT10-55170611 | Height 11 mm | In distribution |
| V070-61709P | In distribution | |
| 22-0469-14 | Length 45 mm | In distribution |
| V070-61713P | In distribution | |
| V070-61715P | In distribution | |
| 22-0466-27 | Width 22 mm | In distribution |
| VT10-40170615 | Length 40 mm | In distribution |
| 22-0468-22 | Length 55 mm | In distribution |
| VT10-45170613 | Width 17 mm | In distribution |
| 22-0469-02 | Length 45 mm | In distribution |
| 22-0466-04 | Length 55 mm | In distribution |
| 22-0467-09 | Length 50 mm | In distribution |
| 22-0468-17 | Width 22 mm | In distribution |
| 22-0467-03 | Length 50 mm | In distribution |
| VT10-60170608 | Height 8 mm | In distribution |
| 22-0469-09 | Width 17 mm | In distribution |
| 22-0466-26 | Height 17 mm | In distribution |
| 22-0468-21 | Length 50 mm | In distribution |
| 22-0467-21 | Length 50 mm | In distribution |
| V070-A2215P | In distribution | |
| V070-02215P | In distribution | |
| 22-0466-19 | Width 22 mm | In distribution |
| VT10-50170613 | Length 50 mm | In distribution |
| VT10-65170613 | Width 17 mm | In distribution |
| 22-0469-28 | Height 17 mm | In distribution |
| 22-0468-27 | Width 22 mm | In distribution |
| VT10-50220007 | Length 50 mm | In distribution |
| V070-01775P | In distribution | |
| 22-0467-30 | Width 17 mm | In distribution |
| 22-0489-06 | Height 7.5 mm | In distribution |
| 22-0468-08 | Length 45 mm | In distribution |
| V070-01713P | In distribution | |
| 22-0475-03 | Height 7.5 mm | In distribution |
| V070-122217P | In distribution | |
| VT10-40170617 | Height 17 mm | In distribution |
| V070-62215P | In distribution | |
| 22-0469-30 | Length 65 mm | In distribution |
| V070-121715P | In distribution | |
| V070-62209P | In distribution | |
| 22-0466-20 | Height 15 mm | In distribution |
| 22-0490-04 | Width 17 mm | In distribution |
| 22-0468-03 | Width 22 mm | In distribution |
| 22-0466-13 | Height 13 mm | In distribution |
| V070-A2211P | In distribution | |
| 22-0468-30 | Width 22 mm | In distribution |
| 22-0466-08 | Height 11 mm | In distribution |
| VT10-65220007 | Height 7.5 mm | In distribution |
| 22-0466-05 | Width 22 mm | In distribution |
| 22-0467-20 | Length 45 mm | In distribution |
| VT10-60220007 | Width 22 mm | In distribution |
| VT10-55170613 | Height 13 mm | In distribution |
| 22-0469-26 | Height 17 mm | In distribution |
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
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.