GluOn-IF Stand-Alone Acif Cage System
The CYGNUS-C Standalone ACIF System cages are designed for restoring the height of the intervertebral space after resection of the disc while also providing biomechanical stability with the…
The CYGNUS-C Standalone ACIF System cages are designed for restoring the height of the intervertebral space after resection of the disc while also providing biomechanical stability with the addition on an integrated plate. This integrated plate allows for the user to bypass using an additional plate as seen with traditional ACIF spacers. The CYGNUS-C Standalone ACIF System devices consist of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The Subject device also contains supplementary fixation screw. The intervertebral body fusion devices are made of hydroxyapatite polyether-ether-ketone (HA PEEK OPTIMA LT1) body with a titanium alloy (Ti-6Al-4V) plate and X-ray (radioopaque) markers made of tantalum. The supplementary screws are made up of titanium alloy (Ti-6Al-4V).
5manufacturers in China registered for this device type
184catalogue numbers in this listing
2510(k) clearances naming this product code
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 | GS Medical Co., Ltd., South Korea |
|---|---|
| FDA product code | OVE |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Manufacturer |
| 510(k) | K222041 |
| Record published | 2023-02-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6080-0017 | In distribution | |
| 6004-0007 | In distribution | |
| 6010-2008 | In distribution | |
| 6080-0016 | In distribution | |
| 6006-1209 | In distribution | |
| 6002-1209 | In distribution | |
| 6090-1012 | In distribution | |
| 6010-6006 | In distribution | |
| 6080-1020 | In distribution | |
| 6080-0013 | In distribution | |
| 6004-1206 | In distribution | |
| 6004-0810 | In distribution | |
| 6010-6009 | In distribution | |
| 6091-1011 | In distribution | |
| 6080-1018 | In distribution | |
| 6091-0011 | In distribution | |
| 6090-0020 | In distribution | |
| 6090-1011 | In distribution | |
| 6006-1212 | In distribution | |
| 6090-1017 | In distribution | |
| 6004-0809 | In distribution | |
| 6006-0806 | In distribution | |
| 6006-1208 | In distribution | |
| 6006-0805 | In distribution | |
| 6080-0011 | In distribution | |
| 6002-1207 | In distribution | |
| 6090-0011 | In distribution | |
| 6004-0008 | In distribution | |
| 6010-2009 | In distribution | |
| 6004-1212 | In distribution | |
| 6002-0012 | In distribution | |
| 6002-1206 | In distribution | |
| 6081-0015 | In distribution | |
| 6091-1016 | In distribution | |
| 6090-1016 | In distribution | |
| 6090-1015 | In distribution | |
| 6002-1212 | In distribution | |
| 6004-1210 | In distribution | |
| 6002-0007 | In distribution | |
| 6006-1205 | In distribution | |
| 6080-0014 | In distribution | |
| 6006-0812 | In distribution | |
| 6090-0013 | In distribution | |
| 6002-0011 | In distribution | |
| 6090-0010 | In distribution | |
| 6081-1016 | In distribution | |
| 6091-1013 | In distribution | |
| 6006-0810 | In distribution | |
| 6004-1208 | In distribution | |
| 6090-0014 | In distribution | |
| 6010-4005 | In distribution | |
| 6080-1016 | In distribution | |
| 6080-1015 | In distribution | |
| 6010-6007 | In distribution | |
| 6081-0012 | In distribution | |
| 6002-1210 | In distribution | |
| 6091-0020 | In distribution | |
| 6002-0005 | In distribution | |
| 6010-2011 | In distribution | |
| 6004-1205 | In distribution | |
| 6091-1015 | In distribution | |
| 6002-0805 | In distribution | |
| 6010-6012 | In distribution | |
| 6004-0811 | In distribution | |
| 6004-0812 | In distribution | |
| 6091-0015 | In distribution | |
| 6091-0016 | In distribution | |
| 6081-1020 | In distribution | |
| 6081-1010 | In distribution | |
| 6081-1015 | In distribution | |
| 6002-0808 | In distribution | |
| 6091-0018 | In distribution | |
| 6080-0010 | In distribution | |
| 6080-0012 | In distribution | |
| 6010-2007 | In distribution | |
| 6080-1013 | In distribution | |
| 6081-1017 | In distribution | |
| 6010-4009 | In distribution | |
| 6002-0812 | In distribution | |
| 6081-0010 | In distribution | |
| 6090-0012 | In distribution | |
| 6004-0011 | In distribution | |
| 6081-0017 | In distribution | |
| 6006-0807 | In distribution | |
| 6010-6005 | In distribution | |
| 6080-1019 | In distribution | |
| 6004-0009 | In distribution | |
| 6004-0006 | In distribution | |
| 6090-0018 | In distribution | |
| 6006-0808 | In distribution | |
| 6002-0810 | In distribution | |
| 6090-1010 | In distribution | |
| 6006-0012 | In distribution | |
| 6004-1209 | In distribution | |
| 6002-1208 | In distribution | |
| 6004-0808 | In distribution | |
| 6006-0010 | In distribution | |
| 6010-2012 | In distribution | |
| 6010-4012 | In distribution | |
| 6010-2006 | In distribution | |
| 6091-1020 | In distribution | |
| 6091-0019 | In distribution | |
| 6080-1012 | In distribution | |
| 6010-2005 | In distribution | |
| 6080-0015 | In distribution | |
| 6091-1019 | In distribution | |
| 6010-6010 | In distribution | |
| 6080-1014 | In distribution | |
| 6081-1011 | In distribution | |
| 6091-0017 | In distribution | |
| 6080-0020 | In distribution | |
| 6004-0012 | In distribution | |
| 6090-1014 | In distribution | |
| 6004-1207 | In distribution | |
| 6006-0006 | In distribution | |
| 6090-0017 | In distribution | |
| 6002-0807 | In distribution | |
| 6081-0013 | In distribution | |
| 6081-0018 | In distribution | |
| 6010-4010 | In distribution | |
| 6010-4011 | In distribution | |
| 6002-0806 | In distribution | |
| 6090-0019 | In distribution | |
| 6002-1205 | In distribution | |
| 6081-1012 | In distribution | |
| 6002-1211 | In distribution | |
| 6081-0011 | In distribution | |
| 6002-0811 | In distribution | |
| 6091-0010 | In distribution | |
| 6006-0811 | In distribution | |
| 6091-0012 | In distribution | |
| 6090-0016 | In distribution | |
| 6091-1012 | In distribution | |
| 6080-1011 | In distribution | |
| 6081-1018 | In distribution | |
| 6091-1010 | In distribution | |
| 6006-1206 | In distribution | |
| 6091-1018 | In distribution | |
| 6091-1017 | In distribution | |
| 6006-0809 | In distribution | |
| 6010-4006 | In distribution | |
| 6010-6011 | In distribution | |
| 6006-1211 | In distribution | |
| 6006-1210 | In distribution | |
| 6010-4007 | In distribution | |
| 6081-0014 | In distribution | |
| 6091-0014 | In distribution | |
| 6004-0010 | In distribution | |
| 6004-0805 | In distribution | |
| 6006-0007 | In distribution | |
| 6090-1018 | In distribution | |
| 6010-4008 | In distribution | |
| 6081-0020 | In distribution | |
| 6010-6008 | In distribution | |
| 6004-0005 | In distribution | |
| 6081-1019 | In distribution | |
| 6006-0011 | In distribution | |
| 6006-0009 | In distribution | |
| 6002-0010 | In distribution | |
| 6004-0806 | In distribution | |
| 6004-0807 | In distribution | |
| 6091-0013 | In distribution | |
| 6004-1211 | In distribution | |
| 6090-0015 | In distribution | |
| 6006-0008 | In distribution | |
| 6080-0018 | In distribution | |
| 6090-1013 | In distribution | |
| 6080-0019 | In distribution | |
| 6006-0005 | In distribution | |
| 6080-1017 | In distribution | |
| 6091-1014 | In distribution | |
| 6081-1014 | In distribution | |
| 6090-1019 | In distribution | |
| 6010-2010 | In distribution | |
| 6081-0016 | In distribution | |
| 6002-0006 | In distribution | |
| 6090-1020 | In distribution | |
| 6080-1010 | In distribution | |
| 6002-0809 | In distribution | |
| 6002-0009 | In distribution | |
| 6002-0008 | In distribution | |
| 6006-1207 | In distribution | |
| 6081-1013 | In distribution | |
| 6081-0019 | 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 |
|---|---|
| K231808 | 2023-07-20 |
| K222041 | 2023-02-09 |
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.