Acis
Acis Implant-Sterile PARALLEL/STANDARD-10MM Height
7manufacturers in China registered for this device type
137catalogue numbers in this listing
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 | Synthes Gmbh, Switzerland |
|---|---|
| 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, Exporter |
| 510(k) | K120275 |
| Record published | 2015-09-14 |
| Record revised | 2022-04-27 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| 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 |
|---|---|---|
| 08.843.112 | In distribution | |
| 08.843.210 | In distribution | |
| 08.843.711S | In distribution | |
| 08.843.008 | In distribution | |
| 08.843.709 | In distribution | |
| 08.843.806S | In distribution | |
| 08.843.407S | In distribution | |
| 08.843.106 | In distribution | |
| 08.843.610S | In distribution | |
| 08.843.406 | In distribution | |
| 08.843.110S | In distribution | |
| 08.843.206 | In distribution | |
| 08.843.811S | In distribution | |
| 08.843.808S | In distribution | |
| 08.843.011S | In distribution | |
| 08.843.812S | In distribution | |
| 08.843.805S | In distribution | |
| 08.843.105 | In distribution | |
| 08.843.606S | In distribution | |
| 08.843.406S | In distribution | |
| 08.843.605S | In distribution | |
| 08.843.710 | In distribution | |
| 08.843.010 | In distribution | |
| 08.843.806 | In distribution | |
| 08.843.708 | In distribution | |
| 08.843.805 | In distribution | |
| 08.843.512S | In distribution | |
| 08.843.212 | In distribution | |
| 08.843.405 | In distribution | |
| 08.843.409S | In distribution | |
| 08.843.709S | In distribution | |
| 08.843.610 | In distribution | |
| 08.843.605 | In distribution | |
| 08.843.407 | In distribution | |
| 08.843.005 | In distribution | |
| 08.843.505S | In distribution | |
| 08.843.105S | In distribution | |
| 08.843.107 | In distribution | |
| 08.843.809S | In distribution | |
| 08.843.507S | In distribution | |
| 08.843.112S | In distribution | |
| 08.843.012 | In distribution | |
| 08.843.109 | In distribution | |
| 08.843.405S | In distribution | |
| 08.843.810 | In distribution | |
| 08.843.307 | In distribution | |
| 08.843.712 | In distribution | |
| 08.843.309S | In distribution | |
| 08.843.111S | In distribution | |
| 08.843.707S | In distribution | |
| 08.843.109S | In distribution | |
| 08.843.408 | In distribution | |
| 08.843.810S | In distribution | |
| 08.843.110 | In distribution | |
| 08.843.706S | In distribution | |
| 08.843.308S | In distribution | |
| 08.843.008S | In distribution | |
| 08.843.506S | In distribution | |
| 08.843.410S | In distribution | |
| 08.843.208S | In distribution | |
| 08.843.211S | In distribution | |
| 08.843.210S | In distribution | |
| 08.843.412S | In distribution | |
| 08.843.708S | In distribution | |
| 08.843.311 | In distribution | |
| 08.843.011 | In distribution | |
| 08.843.312 | In distribution | |
| 08.843.308 | In distribution | |
| 08.843.209 | In distribution | |
| 08.843.108S | In distribution | |
| 08.843.207 | In distribution | |
| 08.843.807S | In distribution | |
| 08.843.510S | In distribution | |
| 08.843.006 | In distribution | |
| 08.843.009S | In distribution | |
| 08.843.612S | In distribution | |
| 08.843.508S | In distribution | |
| 08.843.309 | In distribution | |
| 08.843.711 | In distribution | |
| 08.843.311S | In distribution | |
| 08.843.307S | In distribution | |
| 08.843.306S | In distribution | |
| 08.843.306 | In distribution | |
| 08.843.608 | In distribution | |
| 08.843.104S | In distribution | |
| 08.843.705 | In distribution | |
| 08.843.705S | In distribution | |
| 08.843.007S | In distribution | |
| 08.843.212S | In distribution | |
| 08.843.005S | In distribution | |
| 08.843.509S | In distribution | |
| 08.843.106S | In distribution | |
| 08.843.408S | In distribution | |
| 08.843.206S | In distribution | |
| 08.843.108 | In distribution | |
| 08.843.207S | In distribution | |
| 08.843.111 | In distribution | |
| 08.843.305 | In distribution | |
| 08.843.811 | In distribution | |
| 08.843.809 | In distribution | |
| 08.843.211 | In distribution | |
| 08.843.010S | In distribution | |
| 08.843.611S | In distribution | |
| 08.843.305S | In distribution | |
| 08.843.607S | In distribution | |
| 08.843.310 | In distribution | |
| 08.843.808 | In distribution | |
| 08.843.310S | In distribution | |
| 08.843.511S | In distribution | |
| 08.843.411S | In distribution | |
| 08.843.009 | In distribution | |
| 08.843.609S | In distribution | |
| 08.843.410 | In distribution | |
| 08.843.409 | In distribution | |
| 08.843.209S | In distribution | |
| 08.843.312S | In distribution | |
| 08.843.706 | In distribution | |
| 08.843.707 | In distribution | |
| 08.843.412 | In distribution | |
| 08.843.107S | In distribution | |
| 08.843.612 | In distribution | |
| 08.843.710S | In distribution | |
| 08.843.205S | In distribution | |
| 08.843.006S | In distribution | |
| 08.843.611 | In distribution | |
| 08.843.007 | In distribution | |
| 08.843.606 | In distribution | |
| 08.843.205 | In distribution | |
| 08.843.607 | In distribution | |
| 08.843.411 | In distribution | |
| 08.843.807 | In distribution | |
| 08.843.812 | In distribution | |
| 08.843.208 | In distribution | |
| 08.843.712S | In distribution | |
| 08.843.609 | In distribution | |
| 08.843.012S | In distribution | |
| 08.843.608S | 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.