Irix-C Cervical Integrated Fusion System
IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 0°, 12mm, PC
5manufacturers in China registered for this device type
143catalogue 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 | Xtant Medical Holdings, Inc., 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, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K162944 |
| Record published | 2015-10-12 |
| Record revised | 2021-06-03 (version 5) |
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 |
| Sizes | Height 5 to 12 mm; length 13 to 14 mm; width 16 to 18 mm; angle 7 ° |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X066-181407L-PC | Angle 7 ° | In distribution |
| X066-161311TP | Width 16 mm | In distribution |
| X066-161305P | Width 16 mm | In distribution |
| X066-181412TL | Height 12 mm | In distribution |
| X066-161309TL-PC | Width 16 mm | In distribution |
| X066-161309TP-PC | Height 9 mm | In distribution |
| X066-161305TP | Length 13 mm | In distribution |
| X066-161312P-PC | Angle 0 Degree | In distribution |
| X066-181411L | Height 11 mm | In distribution |
| X066-181405P-PC | Angle 0 Degree | In distribution |
| X066-181408L | Width 18 mm | In distribution |
| X066-161305L-PC | Width 16 mm | In distribution |
| X066-161307TL-PC | Width 16 mm | In distribution |
| X066-161309TL | Angle 7 ° | In distribution |
| X066-161305TP-PC | Length 13 mm | In distribution |
| X066-181405TP-PC | Width 18 mm | In distribution |
| X066-181412L-PC | Length 14 mm | In distribution |
| X066-161309P-PC | Length 13 mm | In distribution |
| X066-161307L-PC | Length 13 mm | In distribution |
| X066-181410TP | Angle 0 Degree | In distribution |
| X066-181408P | Height 8 mm | In distribution |
| X066-181406L | Width 18 mm | In distribution |
| X066-181412TP-PC | Width 18 mm | In distribution |
| X066-161309TP | Height 9 mm | In distribution |
| X066-3514SD | In distribution | |
| X066-161312TL-PC | Width 16 mm | In distribution |
| X066-181407L | Angle 7 ° | In distribution |
| X066-181405L-PC | Height 5 mm | In distribution |
| X066-161308P | Angle 0 Degree | In distribution |
| X066-161305L | Angle 7 ° | In distribution |
| X066-161308P-PC | Height 8 mm | In distribution |
| X066-181411TL-PC | Width 18 mm | In distribution |
| X066-181408L-PC | Width 18 mm | In distribution |
| X066-3717 | In distribution | |
| X066-161305TL | Angle 7 ° | In distribution |
| X066-181409TL-PC | Width 18 mm | In distribution |
| X066-3715 | In distribution | |
| X066-181407TL-PC | Length 14 mm | In distribution |
| X066-161310TP | Length 13 mm | In distribution |
| X066-161310L-PC | Width 16 mm | In distribution |
| X066-161305P-PC | Angle 0 Degree | In distribution |
| X066-161311TP-PC | Height 11 mm | In distribution |
| X066-161310TL-PC | Width 16 mm | In distribution |
| X066-181410L-PC | Width 18 mm | In distribution |
| X066-161311TL-PC | Angle 7 ° | In distribution |
| X066-161310TP-PC | Height 10 mm | In distribution |
| X066-161306L-PC | Angle 7 ° | In distribution |
| X066-161308TL | Angle 7 ° | In distribution |
| X066-181410TL | Length 14 mm | In distribution |
| X066-3516SD | In distribution | |
| X066-161307TP | Height 7 mm | In distribution |
| X066-161306P-PC | Length 13 mm | In distribution |
| X066-181409P-PC | Height 9 mm | In distribution |
| X066-3512SD | In distribution | |
| X066-161310P-PC | Angle 0 Degree | In distribution |
| X066-161311P | Width 16 mm | In distribution |
| X066-181411TP-PC | Width 18 mm | In distribution |
| X066-181406TL-PC | Height 6 mm | In distribution |
| X066-161312L | Width 16 mm | In distribution |
| X066-181410P-PC | Width 18 mm | In distribution |
| X066-161311L | Length 13 mm | In distribution |
| X066-181410TP-PC | Width 18 mm | In distribution |
| X066-181411L-PC | Width 18 mm | In distribution |
| X066-181410L | Width 18 mm | In distribution |
| X066-161308TP | Angle 0 Degree | In distribution |
| X066-161312P | Height 12 mm | In distribution |
| X066-181407TP | Width 18 mm | In distribution |
| X066-181412L | Height 12 mm | In distribution |
| X066-161310TL | Length 13 mm | In distribution |
| X066-161312L-PC | Width 16 mm | In distribution |
| X066-161306TP | Length 13 mm | In distribution |
| X066-161306P | Width 16 mm | In distribution |
| X066-181407TL | Length 14 mm | In distribution |
| X066-181410P | Angle 0 Degree | In distribution |
| X066-181407TP-PC | Length 14 mm | In distribution |
| X066-181405TL | Length 14 mm | In distribution |
| X066-161307TP-PC | Length 13 mm | In distribution |
| X066-181407P | Length 14 mm | In distribution |
| X066-181411TL | Width 18 mm | In distribution |
| X066-3520SD | In distribution | |
| X066-161311L-PC | Angle 7 ° | In distribution |
| X066-3518ST | In distribution | |
| X066-161307P | Length 13 mm | In distribution |
| X066-161308L-PC | Angle 7 ° | In distribution |
| X066-161306L | Length 13 mm | In distribution |
| X066-161306TP-PC | Length 13 mm | In distribution |
| X066-161308TL-PC | Angle 7 ° | In distribution |
| X066-3512ST | In distribution | |
| X066-181412P | Length 14 mm | In distribution |
| X066-161312TP-PC | Width 16 mm | In distribution |
| X066-181406P-PC | Height 6 mm | In distribution |
| X066-181408TL | Length 14 mm | In distribution |
| X066-181405L | Height 5 mm | In distribution |
| X066-181412P-PC | Length 14 mm | In distribution |
| X066-181408P-PC | Height 8 mm | In distribution |
| X066-0007 | In distribution | |
| X066-161305TL-PC | Angle 7 ° | In distribution |
| X066-181408TL-PC | Angle 7 ° | In distribution |
| X066-3719 | In distribution | |
| X066-161309L-PC | Length 13 mm | In distribution |
| X066-181408TP | Length 14 mm | In distribution |
| X066-161306TL-PC | Width 16 mm | In distribution |
| X066-3713 | In distribution | |
| X066-161306TL | Angle 7 ° | In distribution |
| X066-161308L | Height 8 mm | In distribution |
| X066-161310P | Height 10 mm | In distribution |
| X066-181412TL-PC | Width 18 mm | In distribution |
| X066-161309P | Angle 0 Degree | In distribution |
| X066-181405TL-PC | Height 5 mm | In distribution |
| X066-161307L | Width 16 mm | In distribution |
| X066-161312TP | Length 13 mm | In distribution |
| X066-181410TL-PC | Length 14 mm | In distribution |
| X066-181406L-PC | Length 14 mm | In distribution |
| X066-181409P | Width 18 mm | In distribution |
| X066-161307TL | Angle 7 ° | In distribution |
| X066-181406TP | Angle 0 Degree | In distribution |
| X066-3520ST | In distribution | |
| X066-181411P | Width 18 mm | In distribution |
| X066-181406P | Width 18 mm | In distribution |
| X066-3516ST | In distribution | |
| X066-181405TP | Width 18 mm | In distribution |
| X066-161311TL | Angle 7 ° | In distribution |
| X066-161311P-PC | Width 16 mm | In distribution |
| X066-181409TL | Width 18 mm | In distribution |
| X066-181411TP | Height 11 mm | In distribution |
| X066-181409TP | Height 9 mm | In distribution |
| X066-181409L | Width 18 mm | In distribution |
| X066-3721 | In distribution | |
| X066-181408TP-PC | Angle 0 Degree | In distribution |
| X066-181409TP-PC | Length 14 mm | In distribution |
| X066-161310L | Height 10 mm | In distribution |
| X066-181405P | Height 5 mm | In distribution |
| X066-161307P-PC | Angle 0 Degree | In distribution |
| X066-181411P-PC | Width 18 mm | In distribution |
| X066-181409L-PC | Angle 7 ° | In distribution |
| X066-181412TP | Length 14 mm | In distribution |
| X066-161308TP-PC | Length 13 mm | In distribution |
| X066-3514ST | In distribution | |
| X066-181406TP-PC | Width 18 mm | In distribution |
| X066-161312TL | Angle 7 ° | In distribution |
| X066-161309L | Length 13 mm | In distribution |
| X066-181406TL | Angle 7 ° | In distribution |
| X066-181407P-PC | Length 14 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.