Cylox ST 8°
45 catalogue numbers from Cervical cage, angled, listed by Signus Medizintechnik Gmbh, Germany, under Intervertebral Fusion Device With Integrated Fixation, Cervical. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
45catalogue numbers in this listing
1510(k) clearance
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 | Signus Medizintechnik Gmbh, Germany |
|---|---|
| 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, Exporter |
| 510(k) | K243188 |
| Record published | 2025-09-01 |
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 |
| Storage | Storage environment temperature 0 to 35 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Cervical cage, angled | 9x16x14mm | In distribution |
| Cervical cage integrated, stand alone, angled | 8x15x12mm | In distribution |
| Cervical cage, angled | 10x18x15mm | In distribution |
| Cervical cage integrated, stand alone, angled | 7x18x15mm | In distribution |
| Cervical cage integrated, stand alone, angled | 7x15x12mm | In distribution |
| Cervical cage, angled | 6x18x15mm | In distribution |
| Cervical cage integrated, stand alone, angled | 8x16x14mm | In distribution |
| Cervical cage integrated, stand alone, angled | 11x18x15mm | In distribution |
| Cervical cage integrated, stand alone, angled | 8x18x15mm | In distribution |
| Cervical cage, angled | 4x18x15mm | In distribution |
| Cervical cage, angled | 8x18x15mm | In distribution |
| Cervical cage integrated, stand alone, angled | 9x15x12mm | In distribution |
| Cervical cage, angled | 5x18x15mm | In distribution |
| Cervical cage, angled | 10x15x12mm | In distribution |
| Cervical cage integrated, stand alone, angled | 5x15x12mm | In distribution |
| Cervical cage, angled | 10x16x14mm | In distribution |
| Cervical cage, angled | 9x15x12mm | In distribution |
| Cervical cage integrated, stand alone, angled | 5x18x15mm | In distribution |
| Cervical cage integrated, stand alone, angled | 11x16x14mm | In distribution |
| Cervical cage integrated, stand alone, angled | 9x16x14mm | In distribution |
| Cervical cage integrated, stand alone, angled | 6x15x12mm | In distribution |
| Cervical cage, angled | 6x15x12mm | In distribution |
| Cervical cage integrated, stand alone, angled | 7x16x14mm | In distribution |
| Cervical cage integrated, stand alone, angled | 5x16x14mm | In distribution |
| Cervical cage, angled | 5x15x12mm | In distribution |
| Cervical cage integrated, stand alone, angled | 11x15x12mm | In distribution |
| Cervical cage, angled | 11x16x14mm | In distribution |
| Cervical cage, angled | 8x16x14mm | In distribution |
| Cervical cage, angled | 6x16x14mm | In distribution |
| Cervical cage, angled | 8x15x12mm | In distribution |
| Cervical cage, angled | 7x15x12mm | In distribution |
| Cervical cage integrated, stand alone, angled | 9x18x15mm | In distribution |
| Cervical cage integrated, stand alone, angled | 10x18x15mm | In distribution |
| Cervical cage, angled | 9x18x15mm | In distribution |
| Cervical cage, angled | 4x15x12mm | In distribution |
| Cervical cage, angled | 4x16x14mm | In distribution |
| Cervical cage, angled | 7x16x14mm | In distribution |
| Cervical cage, angled | 11x18x15mm | In distribution |
| Cervical cage, angled | 11x15x12mm | In distribution |
| Cervical cage, angled | 5x16x14mm | In distribution |
| Cervical cage integrated, stand alone, angled | 6x16x14mm | In distribution |
| Cervical cage integrated, stand alone, angled | 10x15x12mm | In distribution |
| Cervical cage, angled | 7x18x15mm | In distribution |
| Cervical cage integrated, stand alone, angled | 10x16x14mm | In distribution |
| Cervical cage integrated, stand alone, angled | 6x18x15mm | 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 |
|---|---|
| K243188 | 2025-02-11 |
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.