Sterispine CC
Sterispine CC is a standalone cervical interbody fusion cage used with its own bone screws and autograft. It treats degenerative disc disease at one level between C2 and T1 in skeletally…
Sterispine CC is a standalone cervical interbody fusion cage used with its own bone screws and autograft. It treats degenerative disc disease at one level between C2 and T1 in skeletally mature patients after six weeks of nonoperative treatment.
The cage uses VESTAKEEP PEEK with a tantalum marker for radiographic localization. Titanium alloy screws secure the cage; the set includes two fixation screws and two rescue screws, with only two screws implanted in the cage.
Sizes and Supply
Cage heights range from 5 to 10 mm, with two footprint size groups. The system requires no additional supplemental fixation. Implants are supplied sterile together with a sterile single-use surgical instrument set.
Who Else Makes It
Concentrated in Zhejiang (2), Guangdong (1), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Safe Orthopaedics SAS, France |
|---|---|
| FDA product code | OVE |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K162531 |
| Record published | 2020-06-26 |
| Record revised | 2025-07-14 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KITCCS10L | In distribution | |
| KITCCS05S | In distribution | |
| KITCCS06L | In distribution | |
| KITCCANC | In distribution | |
| KITCCS08S | In distribution | |
| KITCCS07S | In distribution | |
| KITCCS07L | In distribution | |
| KITCCS09L | In distribution | |
| KITCCS05L | In distribution | |
| KITCCS06S | In distribution | |
| KITCCS08L | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| IdentiTi | Alphatec Spine, Inc. | 630 |
| Dolomite | Astura Medical | 607 |
| CoRoent | Nuvasive, Inc. | 580 |
| Aeon-C | Diomedical Co., Ltd. | 508 |
| Tomcat™ Cervical Spinal System | Choice Spine, LP | 468 |
| Shoreline ACS | Seaspine Orthopedics Corporation | 428 |
| Zavation | Zavation | 423 |
| Alta™ Stand-Alone Interbody Fusion System | Biomet Spine | 404 |
| Unison™-C Anterior Cervical Fixation System | Pioneer Surgical Technology, Inc. | 334 |
| Chesapeake® Stabilization System | VB Spine LLC | 272 |
| UniSpace® Stand-Alone C Cage | CG MedTech Co., Ltd. | 260 |
| Solitaire-C Cervical Spacer | Biomet Spine | 256 |
Showing 12 of 391. All products under Intervertebral Fusion Device With Integrated Fixation, Cervical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K162531 | 2016-12-29 |
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.