Stable-C Interbody System
Stable-C Interbody, 10X20X18MM, 12 DEG
5manufacturers in China registered for this device type
40catalogue numbers in this listing
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 | Nexus Spine, L.L.C., United States |
|---|---|
| FDA product code | OVE |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K241467 |
| Record published | 2025-08-31 |
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, expiry date, manufacturing date |
| Sizes | Depth 12 to 18 mm; height 6 to 10 mm; width 14 to 20 mm; weight 14 mg |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 523530s | Width 20 mm | In distribution |
| 523515 | Width 14 mm | In distribution |
| 523530 | Width 20 mm | In distribution |
| 523515s | Width 14 mm | In distribution |
| 523516 | Width 14 mm | In distribution |
| 523517s | Width 14 mm | In distribution |
| 523535s | Width 14 mm | In distribution |
| 523534 | Width 20 mm | In distribution |
| 523538 | Width 14 mm | In distribution |
| 523519s | Width 14 mm | In distribution |
| 523531 | Width 20 mm | In distribution |
| 523554 | Width 20 mm | In distribution |
| 523552 | Width 20 mm | In distribution |
| 523518s | Width 14 mm | In distribution |
| 523539 | Width 14 mm | In distribution |
| 523554s | Width 20 mm | In distribution |
| 523536 | Width 14 mm | In distribution |
| 523535 | Width 14 mm | In distribution |
| 523551s | Width 20 mm | In distribution |
| 523553 | Width 20 mm | In distribution |
| 523534s | Width 20 mm | In distribution |
| 523550s | Width 20 mm | In distribution |
| 523552s | Width 20 mm | In distribution |
| 523537 | Weight 14 mg | In distribution |
| 523532 | Width 20 mm | In distribution |
| 523536s | Width 14 mm | In distribution |
| 523533 | Width 20 mm | In distribution |
| 523550 | Width 20 mm | In distribution |
| 523516s | Width 14 mm | In distribution |
| 523553s | Width 20 mm | In distribution |
| 523551 | Width 20 mm | In distribution |
| 523537s | Width 14 mm | In distribution |
| 523533s | Width 20 mm | In distribution |
| 523518 | Width 14 mm | In distribution |
| 523531s | Width 20 mm | In distribution |
| 523517 | Width 14 mm | In distribution |
| 523519 | Width 14 mm | In distribution |
| 523538s | Width 14 mm | In distribution |
| 523539s | Depth 12 mm | In distribution |
| 523532s | Width 20 mm | 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
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.