Cylox ST
The FDA filing identifies CYLOX ST as an anterior cervical interbody fusion system made up of interbodies, plates, and screws. Its implants are intended for anterior cervical fusion…
The FDA filing identifies CYLOX ST as an anterior cervical interbody fusion system made up of interbodies, plates, and screws.
Its implants are intended for anterior cervical fusion procedures in skeletally mature patients with cervical degenerative disc disease.
Device Description and Stated Use
The summary describes a porous titanium interbody with a central opening that can be packed with autogenous bone graft or specified allograft. It may be used as a standalone implant with integrated fixation or as a construct with a plate and screws.
5manufacturers in China registered for this device type
91catalogue 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 | 2025-09-11 |
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 |
|---|---|---|
| Variable angle screw, self tapping | Ø3,5x10mm | In distribution |
| Variable angle screw, self tapping | Ø4,0x12mm | In distribution |
| Fixed angle screw, self drilling, 2-thread | Ø3,5x16mm | In distribution |
| Fixed angle screw, self tapping | Ø3,5x18mm | In distribution |
| Variable angle screw, self drilling | Ø3,5x18mm | In distribution |
| Fixed angle screw, self drilling, 2-thread | Ø4,0x12mm | In distribution |
| Locking screw, plate | Ø3x9mm | In distribution |
| Fixed angle screw, self tapping | Ø4,0x14mm | In distribution |
| Fixed angle screw, self tapping, 2-thread | Ø3,5x14mm | In distribution |
| Fixed angle screw, self drilling, 2-thread | Ø3,5x10mm | In distribution |
| Variable angle screw, self tapping | Ø3,5x12mm | In distribution |
| Fixed angle screw, self tapping | Ø3,5x14mm | In distribution |
| Fixed angle screw, self tapping | Ø3,5x12mm | In distribution |
| Variable angle screw, self drilling | Ø3,5x16mm | In distribution |
| Cervical plate, 4-hole | 21mm – Cage 11 | In distribution |
| Variable angle screw, self drilling, 2-thread | Ø3,5x16mm | In distribution |
| Variable angle screw, self tapping, 2-thread | Ø4,0x18mm | In distribution |
| Fixed angle screw, self drilling | Ø3,5x12mm | In distribution |
| Variable angle screw, self drilling | Ø4,0x14mm | In distribution |
| Fixed angle screw, self tapping, 2-thread | Ø3,5x16mm | In distribution |
| Fixed angle screw, self tapping, 2-thread | Ø3,5x12mm | In distribution |
| Fixed angle screw, self tapping, 2-thread | Ø4,0x10mm | In distribution |
| Variable angle screw, self tapping, 2-thread | Ø3,5x18mm | In distribution |
| Variable angle screw, self drilling, 2-thread | Ø4,0x18mm | In distribution |
| Fixed angle screw, self drilling, 2-thread | Ø3,5x14mm | In distribution |
| Variable angle screw, self tapping | Ø4,0x10mm | In distribution |
| Variable angle screw, self drilling, 2-thread | Ø3,5x18mm | In distribution |
| Variable angle screw, self tapping, 2-thread | Ø4,0x10mm | In distribution |
| Fixed angle screw, self tapping | Ø4,0x18mm | In distribution |
| Fixed angle screw, self drilling | Ø3,5x18mm | In distribution |
| Fixed angle screw, self drilling | Ø4,0x18mm | In distribution |
| Variable angle screw, self drilling | Ø3,5x10mm | In distribution |
| Fixed angle screw, self drilling, 2-thread | Ø4,0x14mm | In distribution |
| Variable angle screw, self tapping, 2-thread | Ø4,0x16mm | In distribution |
| Cervical plate, 2-hole | 19mm – Cage 9/10 | In distribution |
| Variable angle screw, self tapping | Ø3,5x18mm | In distribution |
| Variable angle screw, self tapping, 2-thread | Ø3,5x10mm | In distribution |
| Fixed angle screw, self drilling | Ø4,0x16mm | In distribution |
| Fixed angle screw, self drilling, 2-thread | Ø4,0x16mm | In distribution |
| Variable angle screw, self drilling | Ø4,0x18mm | In distribution |
| Fixed angle screw, self tapping | Ø3,5x10mm | In distribution |
| Variable angle screw, self tapping, 2-thread | Ø4,0x14mm | In distribution |
| Variable angle screw, self drilling | Ø4,0x16mm | In distribution |
| Variable angle screw, self drilling, 2-thread | Ø4,0x16mm | In distribution |
| Fixed angle screw, self drilling, 2-thread | Ø3,5x18mm | In distribution |
| Cervical plate, 2-hole | 17mm – Cage 7/8 | In distribution |
| Cervical plate, 2-hole | 20mm – Cage 11 | In distribution |
| Fixed angle screw, self tapping, 2-thread | Ø4,0x16mm | In distribution |
| Fixed angle screw, self drilling | Ø4,0x14mm | In distribution |
| Variable angle screw, self tapping, 2-thread | Ø3,5x12mm | In distribution |
| Fixed angle screw, self drilling | Ø3,5x14mm | In distribution |
| Fixed angle screw, self tapping, 2-thread | Ø4,0x18mm | In distribution |
| Locking screw, cage | Ø3×4,5mm | In distribution |
| Variable angle screw, self tapping, 2-thread | Ø4,0x12mm | In distribution |
| Fixed angle screw, self tapping | Ø4,0x16mm | In distribution |
| Cervical plate, 4-hole | 18mm – Cage 7/8 | In distribution |
| Fixed angle screw, self drilling | Ø4,0x10mm | In distribution |
| Fixed angle screw, self tapping | Ø4,0x10mm | In distribution |
| Cervical plate, 2-hole | 15mm – Cage 5/6 | In distribution |
| Fixed angle screw, self tapping, 2-thread | Ø3,5x10mm | In distribution |
| Variable angle screw, self tapping | Ø4,0x14mm | In distribution |
| Fixed angle screw, self drilling | Ø3,5x16mm | In distribution |
| Cervical plate, 4-hole | 14mm – Cage 4 | In distribution |
| Cervical plate, 4-hole | 16mm – Cage 5/6 | In distribution |
| Variable angle screw, self drilling, 2-thread | Ø4,0x10mm | In distribution |
| Fixed angle screw, self tapping, 2-thread | Ø4,0x14mm | In distribution |
| Variable angle screw, self drilling | Ø3,5x12mm | In distribution |
| Variable angle screw, self drilling | Ø4,0x12mm | In distribution |
| Fixed angle screw, self tapping, 2-thread | Ø3,5x18mm | In distribution |
| Variable angle screw, self tapping, 2-thread | Ø3,5x16mm | In distribution |
| Variable angle screw, self drilling, 2-thread | Ø4,0x14mm | In distribution |
| Variable angle screw, self tapping, 2-thread | Ø3,5x14mm | In distribution |
| Variable angle screw, self drilling, 2-thread | Ø4,0x12mm | In distribution |
| Fixed angle screw, self tapping, 2-thread | Ø4,0x12mm | In distribution |
| Variable angle screw, self tapping | Ø4,0x18mm | In distribution |
| Fixed angle screw, self tapping | Ø3,5x16mm | In distribution |
| Fixed angle screw, self drilling, 2-thread | Ø4,0x10mm | In distribution |
| Fixed angle screw, self drilling, 2-thread | Ø3,5x12mm | In distribution |
| Fixed angle screw, self drilling, 2-thread | Ø4,0x18mm | In distribution |
| Variable angle screw, self drilling | Ø4,0x10mm | In distribution |
| Variable angle screw, self drilling, 2-thread | Ø3,5x12mm | In distribution |
| Variable angle screw, self drilling, 2-thread | Ø3,5x10mm | In distribution |
| Variable angle screw, self tapping | Ø4,0x16mm | In distribution |
| Fixed angle screw, self tapping | Ø4,0x12mm | In distribution |
| Fixed angle screw, self drilling | Ø4,0x12mm | In distribution |
| Cervical plate, 4-hole | 20mm – Cage 9/10 | In distribution |
| Variable angle screw, self drilling | Ø3,5x14mm | In distribution |
| Variable angle screw, self tapping | Ø3,5x16mm | In distribution |
| Variable angle screw, self tapping | Ø3,5x14mm | In distribution |
| Fixed angle screw, self drilling | Ø3,5x10mm | In distribution |
| Variable angle screw, self drilling, 2-thread | Ø3,5x14mm | 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.