Integrate-C
INTEGRATE-C is a cervical interbody implant made from one continuous piece of hydroxyapatite-impregnated PEEK. Porous regions extend through the body as part of the monolithic material…
INTEGRATE-C is a cervical interbody implant made from one continuous piece of hydroxyapatite-impregnated PEEK. Porous regions extend through the body as part of the monolithic material structure.
Teeth on the upper and lower surfaces provide initial stability. Tantalum markers support localization during and after placement, while footprints, heights and lordosis vary across the range.
Listed Item
HAPPE Spine – ACDF INTEGRATE-C Medium, 17 x 14 x 14 mm , 10 deg
Fusion Configuration
The system is used through an open anterior approach with bone graft and supplemental fixation. Its intended cervical application includes multiple contiguous levels from C2 to T1 in skeletally mature patients. The porosity belongs to the implant body itself and is not an added surface coating.
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 | Happe Spine, 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, Complaint-file establishment, Manufacturer |
| 510(k) | K222004 |
| Record published | 2023-08-21 |
| Record revised | 2023-12-13 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Small, 15 x 12 x 6 mm , 10 deg | In distribution | |
| Large, 20 x 15 x 6 mm ,7 deg | In distribution | |
| Large, 20 x 15 x 9 mm , 10 deg | In distribution | |
| Medium, 17 x 14 x 14 mm , 10 deg | In distribution | |
| Large, 20 x 15 x 14 mm , 10 deg | In distribution | |
| Medium, 17 x 14 x 9 mm , 10 deg | In distribution | |
| Large, 20 x 15 x 13 mm , 10 deg | In distribution | |
| Medium, 17 x 14 x 8 mm ,7 deg | In distribution | |
| Small, 15 x 12 x 7 mm , 10 deg | In distribution | |
| Large, 20 x 15 x 11 mm , 10 deg | In distribution | |
| Small, 15 x 12 x 14 mm , 10 deg | In distribution | |
| Medium, 17 x 14 x 6 mm , 10 deg | In distribution | |
| Medium, 17 x 14 x 7 mm , 10 deg | In distribution | |
| Medium, 17 x 14 x 9 mm ,7 deg | In distribution | |
| Large, 20 x 15 x 8 mm , 10 deg | In distribution | |
| Large, 20 x 15 x 5 mm , 10 deg | In distribution | |
| Small, 15 x 12 x 11 mm , 10 deg | In distribution | |
| Small, 15 x 12 x 5 mm , 10 deg | In distribution | |
| Medium, 17 x 14 x 14 mm ,7 deg | In distribution | |
| Medium, 17 x 14 x 7 mm ,7 deg | In distribution | |
| Medium, 17 x 14 x 6 mm ,7 deg | In distribution | |
| Large, 20 x 15 x 11 mm ,7 deg | In distribution | |
| Small, 15 x 12 x 10 mm , 10 deg | In distribution | |
| Small, 15 x 12 x 12 mm , 10 deg | In distribution | |
| Medium, 17 x 14 x 12 mm , 10 deg | In distribution | |
| Large, 20 x 15 x 7 mm ,7 deg | In distribution | |
| Large, 20 x 15 x 9 mm ,7 deg | In distribution | |
| Medium, 17 x 14 x 10 mm , 10 deg | In distribution | |
| Small, 15 x 12 x 11 mm ,7 deg | In distribution | |
| Medium, 17 x 14 x 11 mm ,7 deg | In distribution | |
| Medium, 17 x 14 x 10 mm ,7 deg | In distribution | |
| Large, 20 x 15 x 14 mm ,7 deg | In distribution | |
| Large, 20 x 15 x 12 mm , 10 deg | In distribution | |
| Large, 20 x 15 x 13 mm ,7 deg | In distribution | |
| Small, 15 x 12 x 10 mm ,7 deg | In distribution | |
| Small, 15 x 12 x 9 mm , 10 deg | In distribution | |
| Large, 20 x 15 x 12 mm ,7 deg | In distribution | |
| Large, 20 x 15 x 8 mm ,7 deg | In distribution | |
| Large, 20 x 15 x 7 mm , 10 deg | In distribution | |
| Small, 15 x 12 x 5 mm ,7 deg | In distribution | |
| Large, 20 x 15 x 6 mm , 10 deg | In distribution | |
| Small, 15 x 12 x 13 mm , 10 deg | In distribution | |
| Medium, 17 x 14 x 13 mm ,7 deg | In distribution | |
| Medium, 17 x 14 x 5 mm , 10 deg | In distribution | |
| Small, 15 x 12 x 14 mm ,7 deg | In distribution | |
| Small, 15 x 12 x 8 mm , 10 deg | In distribution | |
| Small, 15 x 12 x 7 mm ,7 deg | In distribution | |
| Small, 15 x 12 x 6 mm ,7 deg | In distribution | |
| Small, 15 x 12 x 12 mm ,7 deg | In distribution | |
| Medium, 17 x 14 x 5 mm ,7 deg | In distribution | |
| Large, 20 x 15 x 10 mm ,7 deg | In distribution | |
| Small, 15 x 12 x 8 mm ,7 deg | In distribution | |
| Small, 15 x 12 x 13 mm ,7 deg | In distribution | |
| Large, 20 x 15 x 5 mm ,7 deg | In distribution | |
| Large, 20 x 15 x 10 mm , 10 deg | In distribution | |
| Small, 15 x 12 x 9 mm ,7 deg | In distribution | |
| Medium, 17 x 14 x 13 mm , 10 deg | In distribution | |
| Medium, 17 x 14 x 11 mm , 10 deg | In distribution | |
| Medium, 17 x 14 x 8 mm , 10 deg | In distribution | |
| Medium, 17 x 14 x 12 mm ,7 deg | 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 |
|---|---|
| K222004 | 2023-04-28 |
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.