Ascendant
78 catalogue numbers from 05-090-11-1605, listed by Choice Spine, LP, under Intervertebral Fusion Device With Bone Graft, Cervical. 7 manufacturers in China are registered for 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 | Choice Spine, LP |
|---|---|
| FDA product code | ODP |
| Device type | Intervertebral Fusion Device With Bone Graft, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Record published | 2015-11-16 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | expiry date, serial number |
| Sizes | Height 4 to 12 mm; width 14 to 18 mm; length 12 to 14 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 05-090-11-1605 | Height 5 mm | In distribution |
| 05-090-12-1606 | Height 6 mm | In distribution |
| 05-090-11-1410 | Height 10 mm | In distribution |
| 05-090-12-1609 | Convex | In distribution |
| 05-090-11-1611 | Height 11 mm | In distribution |
| 05-090-12-1605 | Convex | In distribution |
| 05-090-10-1806 | Lordotic | In distribution |
| 05-090-11-1609 | Height 9 mm | In distribution |
| 05-090-11-1610 | Parallel | In distribution |
| 05-090-10-1605 | Height 5 mm | In distribution |
| 05-090-12-1804 | Convex | In distribution |
| 05-090-11-1608 | Parallel | In distribution |
| 05-090-11-1612 | Parallel | In distribution |
| 05-090-11-1408 | Height 8 mm | In distribution |
| 05-090-11-1812 | Height 12 mm | In distribution |
| 05-090-12-1407 | Height 7 mm | In distribution |
| 05-090-10-1606 | Lordotic | In distribution |
| 05-090-12-1411 | Height 11 mm | In distribution |
| 05-090-10-1408 | Lordotic | In distribution |
| 05-090-10-1611 | Height 11 mm | In distribution |
| 05-090-12-1611 | Convex | In distribution |
| 05-090-12-1607 | Convex | In distribution |
| 05-090-11-1409 | Parallel | In distribution |
| 05-090-12-1608 | Height 8 mm | In distribution |
| 05-090-12-1811 | Height 11 mm | In distribution |
| 05-090-11-1806 | Height 6 mm | In distribution |
| 05-090-11-1808 | Height 8 mm | In distribution |
| 05-090-10-1809 | Height 9 mm | In distribution |
| 05-090-11-1809 | Parallel | In distribution |
| 05-090-10-1811 | Height 11 mm | In distribution |
| 05-090-10-1612 | Lordotic | In distribution |
| 05-090-12-1806 | Convex | In distribution |
| 05-090-12-1809 | Height 9 mm | In distribution |
| 05-090-12-1812 | Convex | In distribution |
| 05-090-12-1412 | Convex | In distribution |
| 05-090-11-1607 | Height 7 mm | In distribution |
| 05-090-10-1609 | Height 9 mm | In distribution |
| 05-090-10-1805 | Height 5 mm | In distribution |
| 05-090-12-1805 | Height 5 mm | In distribution |
| 05-090-11-1604 | Parallel | In distribution |
| 05-090-12-1604 | Height 4 mm | In distribution |
| 05-090-10-1808 | Lordotic | In distribution |
| 05-090-10-1610 | Lordotic | In distribution |
| 05-090-12-1406 | Convex | In distribution |
| 05-090-12-1807 | Height 7 mm | In distribution |
| 05-090-12-1408 | Convex | In distribution |
| 05-090-12-1410 | Convex | In distribution |
| 05-090-12-1610 | Height 10 mm | In distribution |
| 05-090-10-1608 | Lordotic | In distribution |
| 05-090-10-1807 | Height 7 mm | In distribution |
| 05-090-11-1407 | Parallel | In distribution |
| 05-090-10-1405 | Height 5 mm | In distribution |
| 05-090-12-1404 | Convex | In distribution |
| 05-090-12-1405 | Height 5 mm | In distribution |
| 05-090-11-1405 | Parallel | In distribution |
| 05-090-10-1812 | Lordotic | In distribution |
| 05-090-11-1804 | Height 4 mm | In distribution |
| 05-090-10-1409 | Height 9 mm | In distribution |
| 05-090-11-1412 | Height 12 mm | In distribution |
| 05-090-11-1805 | Parallel | In distribution |
| 05-090-11-1811 | Parallel | In distribution |
| 05-090-10-1406 | Lordotic | In distribution |
| 05-090-11-1807 | Parallel | In distribution |
| 05-090-10-1412 | Lordotic | In distribution |
| 05-090-10-1410 | Lordotic | In distribution |
| 05-090-11-1406 | Height 6 mm | In distribution |
| 05-090-11-1404 | Height 4 mm | In distribution |
| 05-090-12-1612 | Height 12 mm | In distribution |
| 05-090-12-1810 | Convex | In distribution |
| 05-090-12-1808 | Convex | In distribution |
| 05-090-11-1606 | Parallel | In distribution |
| 05-090-12-1409 | Height 9 mm | In distribution |
| 05-090-10-1810 | Lordotic | In distribution |
| 05-090-10-1411 | Height 11 mm | In distribution |
| 05-090-11-1810 | Height 10 mm | In distribution |
| 05-090-10-1407 | Height 7 mm | In distribution |
| 05-090-11-1411 | Parallel | In distribution |
| 05-090-10-1607 | Height 7 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
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.