ClariVy™
The FDA filing identifies the Vy Spine ClariVy Cervical IBF System as a spacer system for intervertebral fusion in the cervical spine. The spacer may be PEEK or hydroxyapatite-enhanced PEEK…
The FDA filing identifies the Vy Spine ClariVy Cervical IBF System as a spacer system for intervertebral fusion in the cervical spine.
The spacer may be PEEK or hydroxyapatite-enhanced PEEK with tantalum markers, and the system may include titanium-alloy bone screws.
Listed Item
OsteoVy™ PEKK IBF, Sterile, 14×11, 0°, 7mm, OXPEKK IG100
Use and Placement
The filing indicates use for intervertebral body fusion in skeletally mature patients, with autogenous bone graft, and one device per intervertebral space. It specifies use at one cervical level from C3 to T1.
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 | VY Spine, LLC, United States |
|---|---|
| FDA product code | ODP |
| Device type | Intervertebral Fusion Device With Bone Graft, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K212715 |
| Record published | 2026-04-24 |
| Record revised | 2024-08-14 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 02-ITL-1210-09 | In distribution | |
| 02-C-1411-0-07-PK-R | In distribution | |
| 02-ITL-1411-08 | In distribution | |
| 02-ITL-1411-05 | In distribution | |
| 02-ITL-1210-06 | In distribution | |
| 02-ITL-1411-07 | In distribution | |
| 02-ITL-1411-09 | In distribution | |
| 02-C-1411-0-08-PK-R | In distribution | |
| 02-ITL-1210-05 | In distribution | |
| 02-C-1411-0-04-PK-R | In distribution | |
| 02-ITL-1210-08 | In distribution | |
| 02-C-1411-0-04-PH-R | In distribution | |
| 02-IT-001 | In distribution | |
| 02-ITL-1210-04 | In distribution | |
| 02-ITL-1411-04 | In distribution | |
| 02-C-1411-0-06-PK-R | In distribution | |
| 02-ITL-1210-07 | In distribution | |
| 02-ITL-1411-06 | In distribution | |
| 02-C-1411-0-05-PK-R | In distribution | |
| 02-C-1210-7-07-PK-R | 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 |
|---|---|
| K231836 | 2023-10-30 |
| K230414 | 2023-05-12 |
| K223513 | 2023-04-18 |
| K221162 | 2022-11-04 |
| K212715 | 2021-12-20 |
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.