Cornice
Cornice is the listed name for Legend Spine Technologies’ CORNICE Cervical Spacer System. The FDA filing describes an anterior cervical interbody fusion device with a hollow chamber for…
Cornice is the listed name for Legend Spine Technologies’ CORNICE Cervical Spacer System. The FDA filing describes an anterior cervical interbody fusion device with a hollow chamber for bone graft.
The filing indicates use in skeletally mature patients at one or two contiguous cervical levels from C2 to T1, with supplemental fixation. It specifies cervical disc degeneration and/or instability resulting in radiculopathy, myelopathy and/or pain.
Device Function and Details
The spacers are made from either PEEK with tantalum X-ray markers or titanium alloy. The filing says the hollow chamber permits packing with bone graft to facilitate fusion.
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 | Legend Spine Technologies, United States |
|---|---|
| FDA product code | ODP |
| Device type | Intervertebral Fusion Device With Bone Graft, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| 510(k) | K192208 |
| Record published | 2020-10-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CN1714P0611 | In distribution | |
| CN1412P0607 | In distribution | |
| CN-012 | In distribution | |
| CN1412T0609 | In distribution | |
| CN1412P0610 | In distribution | |
| CN-1412-0605-S | In distribution | |
| CN1714P0612 | In distribution | |
| CN1714T0608 | In distribution | |
| CN-1412-0610-S | In distribution | |
| CN1210P0607 | In distribution | |
| CNR-1412-0605-S | In distribution | |
| CN1210P0612 | In distribution | |
| CN1714T0607 | In distribution | |
| CN1714P0608 | In distribution | |
| CN1412P0606 | In distribution | |
| CN-000 | In distribution | |
| CN1412T0606 | In distribution | |
| CN-011 | In distribution | |
| CN1210P0604 | In distribution | |
| CN1412P0611 | In distribution | |
| CN1714P0604 | In distribution | |
| CN1210P0606 | In distribution | |
| CN1412T0608 | In distribution | |
| CN1412P0604 | In distribution | |
| CN1412T0607 | In distribution | |
| CN1714T0609 | In distribution | |
| CN1210P0610 | In distribution | |
| CN-1412-0609-S | In distribution | |
| CN-1412-0607-S | In distribution | |
| CN1714T0606 | In distribution | |
| CN1210P0608 | In distribution | |
| CN1412T0605 | In distribution | |
| CN1714T0612 | In distribution | |
| CN1714P0610 | In distribution | |
| CN-1412-0608-S | In distribution | |
| CN1210P0609 | In distribution | |
| CN1210P0605 | In distribution | |
| CN-1412-0606-S | In distribution | |
| CN1714P0609 | In distribution | |
| CN1412P0612 | In distribution | |
| CN1412P0609 | In distribution | |
| CN1714T0611 | In distribution | |
| CN1714P0606 | In distribution | |
| CN-1412-0611-S | In distribution | |
| CN1412P0608 | In distribution | |
| CN1412T0611 | In distribution | |
| CN1412T0612 | In distribution | |
| CN1412P0605 | In distribution | |
| CN-005 | In distribution | |
| CN1412T0610 | In distribution | |
| CN1714P0607 | In distribution | |
| CN1210P0611 | In distribution | |
| CN1714T0605 | In distribution | |
| CN1714P0605 | In distribution | |
| CN-1412-0612-S | In distribution | |
| CN1714T0610 | In distribution | |
| CN-001 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192208 | 2019-10-09 |
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.