Accufuse Cervical System
Cervical Cage PEEK 12mmx12mmx12mm 7° lordosis
7manufacturers in China registered for this device type
43catalogue numbers in this listing
1510(k) clearance
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 | Absolute Advantage Medical, 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 |
| Record published | 2019-04-24 |
| Record revised | 2022-09-16 (version 6) |
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, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10-12-08 | In distribution | |
| 10-08 | In distribution | |
| C121206 | In distribution | |
| C161407 | In distribution | |
| C161409 | In distribution | |
| 10-12-11 | In distribution | |
| C121208 | In distribution | |
| C161408 | In distribution | |
| C121205 | In distribution | |
| C161406 | In distribution | |
| C181510 | In distribution | |
| C181506 | In distribution | |
| 10-20-04 | In distribution | |
| C181507 | In distribution | |
| C141209 | In distribution | |
| C121209 | In distribution | |
| C181508 | In distribution | |
| C141208 | In distribution | |
| C121207 | In distribution | |
| C141205 | In distribution | |
| C181512 | In distribution | |
| C121212 | In distribution | |
| C141210 | In distribution | |
| C181509 | In distribution | |
| C141206 | In distribution | |
| 10-12-12 | In distribution | |
| C141211 | In distribution | |
| C121210 | In distribution | |
| C161412 | In distribution | |
| C141212 | In distribution | |
| 10-13 | In distribution | |
| C121211 | In distribution | |
| 10-12-09 | In distribution | |
| 10-12-10 | In distribution | |
| 10-12-05 | In distribution | |
| C161411 | In distribution | |
| C141207 | In distribution | |
| C161410 | In distribution | |
| C181511 | In distribution | |
| C181505 | In distribution | |
| 10-12-07 | In distribution | |
| 10-12-06 | In distribution | |
| C161405 | 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 |
|---|---|
| K181471 | 2018-08-29 |
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.