HAtetracell™-C
HAtetracell-C, 16L x 19W x 11H x 12°, Ti 6Al 4V (ELI), HA
7manufacturers in China registered for this device type
155catalogue 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 | Inno-Health Technology Co., Ltd., Taiwan |
|---|---|
| FDA product code | ODP |
| Device type | Intervertebral Fusion Device With Bone Graft, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Contract manufacturer, Contract steriliser, Manufacturer |
| 510(k) | K231899 |
| Record published | 2024-08-31 |
| Record revised | 2025-12-18 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Packaging | Carton |
| Sizes | Length 12 to 16 mm; angle 8 to 12 °; width 14 to 19 mm; height 5 to 12 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 65-16190708 | Length 16 mm | In distribution |
| 65-14171008 | Length 14 mm | In distribution |
| 65-16191112 | Length 16 mm | In distribution |
| 65-13150508 | Length 13 mm | In distribution |
| LS-758-27 | Length 16 mm | In distribution |
| 65-14161108 | Length 14 mm | In distribution |
| 65-16191012 | Length 16 mm | In distribution |
| 65-14170808 | Length 14 mm | In distribution |
| 65-16190712 | Height 7 mm | In distribution |
| 65-12151012 | Length 12 mm | In distribution |
| 65-16181212 | Length 16 mm | In distribution |
| 65-14160508 | Length 14 mm | In distribution |
| 65-12151212 | Length 12 mm | In distribution |
| LS-758-18 | Length 14 mm | In distribution |
| 65-15170712 | Length 15 mm | In distribution |
| 65-14171108 | Length 14 mm | In distribution |
| 65-14170608 | Length 14 mm | In distribution |
| 65-12140912 | Length 12 mm | In distribution |
| 65-12140712 | Length 12 mm | In distribution |
| 65-12150512 | Length 12 mm | In distribution |
| 65-14160908 | Length 14 mm | In distribution |
| 65-12140812 | Length 12 mm | In distribution |
| LS-758-08 | Length 12 mm | In distribution |
| LS-758-22 | Length 16 mm | In distribution |
| 65-13150708 | Length 13 mm | In distribution |
| LS-759-05 | Length 16 mm | In distribution |
| 65-14170912 | Length 14 mm | In distribution |
| 65-13150808 | Length 13 mm | In distribution |
| 65-14160612 | Length 14 mm | In distribution |
| 65-16190912 | Length 16 mm | In distribution |
| 65-14171212 | Length 14 mm | In distribution |
| 65-14161012 | Length 14 mm | In distribution |
| 65-15171212 | Length 15 mm | In distribution |
| 65-14161212 | Length 14 mm | In distribution |
| LS-758-26 | Length 16 mm | In distribution |
| LS-759-03 | Length 15 mm | In distribution |
| 65-15171012 | Length 15 mm | In distribution |
| 65-12150808 | Length 12 mm | In distribution |
| LS-758-06 | Length 12 mm | In distribution |
| 65-15171208 | Length 15 mm | In distribution |
| 65-15170508 | Length 15 mm | In distribution |
| 65-13151108 | Length 13 mm | In distribution |
| LS-758-21 | Length 15 mm | In distribution |
| 65-12151112 | Length 12 mm | In distribution |
| 65-14160808 | Length 14 mm | In distribution |
| 65-12140808 | Length 12 mm | In distribution |
| LS-758-11 | Length 13 mm | In distribution |
| 65-16180708 | Length 16 mm | In distribution |
| 65-14161208 | Length 14 mm | In distribution |
| 65-12141112 | Length 12 mm | In distribution |
| 65-13150612 | Length 13 mm | In distribution |
| 65-12141108 | Length 12 mm | In distribution |
| 65-14171112 | Length 14 mm | In distribution |
| 65-16190508 | Length 16 mm | In distribution |
| 65-12150612 | Length 12 mm | In distribution |
| LS-758-09 | Length 13 mm | In distribution |
| 65-14170712 | Length 14 mm | In distribution |
| LS-758-16 | Length 14 mm | In distribution |
| 65-15171112 | Length 15 mm | In distribution |
| 65-15170708 | Length 15 mm | In distribution |
| 65-16180712 | Length 16 mm | In distribution |
| 65-14170508 | Length 14 mm | In distribution |
| 65-13150608 | Length 13 mm | In distribution |
| 65-15170908 | Length 15 mm | In distribution |
| 65-16180612 | Length 16 mm | In distribution |
| 65-16191108 | Length 16 mm | In distribution |
| 65-16181208 | Length 16 mm | In distribution |
| 65-13150512 | Length 13 mm | In distribution |
| 65-13151012 | Length 13 mm | In distribution |
| 65-15171008 | Length 15 mm | In distribution |
| 65-16181008 | Length 16 mm | In distribution |
| LS-758-25 | Length 16 mm | In distribution |
| 65-12140612 | Length 12 mm | In distribution |
| LS-758-24 | Length 16 mm | In distribution |
| LS-758-19 | Length 15 mm | In distribution |
| 65-14171208 | Length 14 mm | In distribution |
| 65-15170812 | Length 15 mm | In distribution |
| LS-758-05 | Length 12 mm | In distribution |
| LS-758-03 | Length 12 mm | In distribution |
| LS-758-15 | Length 14 mm | In distribution |
| 65-16180908 | Length 16 mm | In distribution |
| 65-15171108 | Length 15 mm | In distribution |
| 65-16190612 | Length 16 mm | In distribution |
| LS-758-23 | Length 16 mm | In distribution |
| 65-12151108 | Length 12 mm | In distribution |
| 65-15170808 | Length 15 mm | In distribution |
| 65-14170812 | Length 14 mm | In distribution |
| 65-12140512 | Length 12 mm | In distribution |
| 65-14161008 | Length 14 mm | In distribution |
| 65-13150908 | Length 13 mm | In distribution |
| 65-13150812 | Length 13 mm | In distribution |
| 65-16180608 | Length 16 mm | In distribution |
| 65-14161112 | Length 14 mm | In distribution |
| 65-14160812 | Length 14 mm | In distribution |
| 65-12150608 | Length 12 mm | In distribution |
| 65-12151208 | Length 12 mm | In distribution |
| 65-14171012 | Length 14 mm | In distribution |
| 65-16190808 | Length 16 mm | In distribution |
| 65-12141212 | Length 12 mm | In distribution |
| LS-758-14 | Length 14 mm | In distribution |
| 65-14170708 | Length 14 mm | In distribution |
| 65-14170612 | Length 14 mm | In distribution |
| 65-12151008 | Length 12 mm | In distribution |
| 65-13150712 | Length 13 mm | In distribution |
| 65-16191212 | Length 16 mm | In distribution |
| LS-758-07 | Length 12 mm | In distribution |
| 65-12140908 | Length 12 mm | In distribution |
| 65-15170912 | Length 15 mm | In distribution |
| 65-16180812 | Length 16 mm | In distribution |
| 65-12150508 | Length 12 mm | In distribution |
| 65-12150708 | Length 12 mm | In distribution |
| 65-12141008 | Length 12 mm | In distribution |
| LS-758-01 | Length 12 mm | In distribution |
| LS-759-02 | Length 14 mm | In distribution |
| LS-758-04 | Length 12 mm | In distribution |
| 65-16180808 | Length 16 mm | In distribution |
| 65-16180912 | Length 16 mm | In distribution |
| 65-15170612 | Length 15 mm | In distribution |
| 65-14160712 | Length 14 mm | In distribution |
| 65-12140708 | Length 12 mm | In distribution |
| 65-14160912 | Length 14 mm | In distribution |
| LS-758-10 | Length 13 mm | In distribution |
| 65-16181108 | Length 16 mm | In distribution |
| 65-16181012 | Length 16 mm | In distribution |
| 65-12150712 | Length 12 mm | In distribution |
| LS-759-04 | Length 16 mm | In distribution |
| LS-758-20 | Length 15 mm | In distribution |
| LS-759-01 | Length 14 mm | In distribution |
| 65-12150912 | Length 12 mm | In distribution |
| 65-16190812 | Length 16 mm | In distribution |
| 65-14160608 | Length 14 mm | In distribution |
| 65-16181112 | Length 16 mm | In distribution |
| 65-16180508 | Length 16 mm | In distribution |
| LS-758-02 | Length 12 mm | In distribution |
| 65-12150908 | Length 12 mm | In distribution |
| 65-16190908 | Length 16 mm | In distribution |
| 65-13151208 | Length 13 mm | In distribution |
| LS-758-17 | Length 14 mm | In distribution |
| 65-13151008 | Length 13 mm | In distribution |
| 65-16191008 | Length 16 mm | In distribution |
| 65-12141012 | Length 12 mm | In distribution |
| 65-13150912 | Length 13 mm | In distribution |
| 65-14160708 | Length 14 mm | In distribution |
| LS-758-12 | Length 13 mm | In distribution |
| 65-12140508 | Length 12 mm | In distribution |
| 65-15170608 | Length 15 mm | In distribution |
| 65-12141208 | Length 12 mm | In distribution |
| 65-12140608 | Length 12 mm | In distribution |
| 65-13151112 | Length 13 mm | In distribution |
| 65-16191208 | Length 16 mm | In distribution |
| 65-13151212 | Length 13 mm | In distribution |
| 65-12150812 | Length 12 mm | In distribution |
| LS-758-13 | Length 14 mm | In distribution |
| 65-16190608 | Length 16 mm | In distribution |
| 65-14170908 | Length 14 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.