TirboLOX-C Cervical Ibfd
TirboLOX-C is a cervical interbody fusion cage range made from titanium alloy using additive manufacturing. A central window accommodates bone graft, while the implant supplies structural…
TirboLOX-C is a cervical interbody fusion cage range made from titanium alloy using additive manufacturing. A central window accommodates bone graft, while the implant supplies structural support between vertebral bodies.
The range includes lordotic, anatomically shaped and parallel configurations in different footprints. These geometries provide different cage forms for the prepared interbody space.
Listed Item
3D Cage – Anatomical (W)15 x (L)12 x (H)10mm
Graft and Fixation
The implants are supplied sterile and placed through an anterior approach for a single cervical disc level within C3 to C7. They are used with autograft or cancellous or corticocancellous allograft and require supplemental fixation.
7manufacturers in China registered for this device type
299catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (2), Shandong (2), Zhejiang (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
| Shanghai Sanyou Medical Co., Ltd. | Shanghai | Shanghai | Manufacturer | 6 |
Record
| Listed by | Captiva Spine, Inc., United States |
|---|---|
| FDA product code | ODP |
| Device type | Intervertebral Fusion Device With Bone Graft, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K181229 |
| Record published | 2020-11-22 |
| Record revised | 2021-04-21 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 18150-1016 | In distribution | |
| 18100-0916 | In distribution | |
| 18155-0616 | In distribution | |
| 18100-1405 | In distribution | |
| 18374-0910 | In distribution | |
| 18100-1216 | In distribution | |
| 18375-0910 | In distribution | |
| 18157-1115 | In distribution | |
| 18150-0815 | In distribution | |
| 18377-1112 | In distribution | |
| 18150-1115 | In distribution | |
| 18305-0708 | In distribution | |
| 18107-1212 | In distribution | |
| 18105-0915 | In distribution | |
| 18305-0910 | In distribution | |
| 18155-0816 | In distribution | |
| 18300-0500 | In distribution | |
| 18157-1215 | In distribution | |
| 18170-0617 | In distribution | |
| 18307-0506 | In distribution | |
| 18100-1117 | In distribution | |
| 18107-1410 | In distribution | |
| 18157-0515 | In distribution | |
| 18175-0616 | In distribution | |
| 18105-1116 | In distribution | |
| 18100-1207 | In distribution | |
| 18155-0715 | In distribution | |
| 18155-0614 | In distribution | |
| 18100-0917 | In distribution | |
| 18170-1116 | In distribution | |
| 18170-1017 | In distribution | |
| 18373-0506 | In distribution | |
| 18304-0506 | In distribution | |
| 18308-0910 | In distribution | |
| 18150-1014 | In distribution | |
| 18107-1207 | In distribution | |
| 18300-1616 | In distribution | |
| 18170-1216 | In distribution | |
| 18312-0300 | In distribution | |
| 18304-0708 | In distribution | |
| 18105-0515 | In distribution | |
| 18107-1115 | In distribution | |
| 18308-0506 | In distribution | |
| 18100-1205 | In distribution | |
| 18354-0910 | In distribution | |
| 18125-1410 | In distribution | |
| 18373-0910 | In distribution | |
| 18100-0715 | In distribution | |
| 18105-0716 | In distribution | |
| 18150-0514 | In distribution | |
| 18100-1210 | In distribution | |
| 18155-1216 | In distribution | |
| 18372-0506 | In distribution | |
| 18351-0910 | In distribution | |
| 18125-1411 | In distribution | |
| 18100-0815 | In distribution | |
| 18170-0516 | In distribution | |
| 18303-0506 | In distribution | |
| 18125-1208 | In distribution | |
| 18170-0517 | In distribution | |
| 18150-1215 | In distribution | |
| 18175-0816 | In distribution | |
| 18105-1016 | In distribution | |
| 18100-1212 | In distribution | |
| 18157-1015 | In distribution | |
| 18125-1409 | In distribution | |
| 18307-0910 | In distribution | |
| 18107-1411 | In distribution | |
| 18157-0614 | In distribution | |
| 18155-0514 | In distribution | |
| 18301-0506 | In distribution | |
| 18150-0715 | In distribution | |
| 18100-1206 | In distribution | |
| 18100-1015 | In distribution | |
| 18105-1215 | In distribution | |
| 18125-1407 | In distribution | |
| 18356-1112 | In distribution | |
| 18150-1015 | In distribution | |
| 18150-0816 | In distribution | |
| 18150-1116 | In distribution | |
| 18307-1112 | In distribution | |
| 18306-0910 | In distribution | |
| 18301-0910 | In distribution | |
| 18155-1115 | In distribution | |
| 18107-1412 | In distribution | |
| 18105-0715 | In distribution | |
| 18150-0714 | In distribution | |
| 18107-1015 | In distribution | |
| 18355-0506 | In distribution | |
| 18374-0708 | In distribution | |
| 18170-1217 | In distribution | |
| 18376-0910 | In distribution | |
| 18303-1112 | In distribution | |
| 18357-0506 | In distribution | |
| 18100-1412 | In distribution | |
| 18353-0708 | In distribution | |
| 18125-1211 | In distribution | |
| 18374-0506 | In distribution | |
| 18155-0916 | In distribution | |
| 18354-1112 | In distribution | |
| 18302-1112 | In distribution | |
| 18170-1016 | In distribution | |
| 18375-0506 | In distribution | |
| 18175-1116 | In distribution | |
| 18374-1112 | In distribution | |
| 18107-0615 | In distribution | |
| 18354-0506 | In distribution | |
| 18170-0717 | In distribution | |
| 18353-0910 | In distribution | |
| 18150-0915 | In distribution | |
| 18100-1410 | In distribution | |
| 18170-0616 | In distribution | |
| 18150-1217 | In distribution | |
| 18157-0715 | In distribution | |
| 18378-0708 | In distribution | |
| 18150-1214 | In distribution | |
| 18150-1216 | In distribution | |
| 18357-0708 | In distribution | |
| 18301-0708 | In distribution | |
| 18306-0708 | In distribution | |
| 18150-0616 | In distribution | |
| 18125-1405 | In distribution | |
| 18155-1114 | In distribution | |
| 18355-0708 | In distribution | |
| 18300-1614 | In distribution | |
| 18125-1412 | In distribution | |
| 18371-0506 | In distribution | |
| 18372-0708 | In distribution | |
| 18375-1112 | In distribution | |
| 18302-0910 | In distribution | |
| 18107-0515 | In distribution | |
| 18125-1406 | In distribution | |
| 18302-0506 | In distribution | |
| 18155-0716 | In distribution | |
| 18170-0916 | In distribution | |
| 18100-1116 | In distribution | |
| 18157-0814 | In distribution | |
| 18358-1112 | In distribution | |
| 18300-0600 | In distribution | |
| 18125-1209 | In distribution | |
| 18170-1117 | In distribution | |
| 18100-1408 | In distribution | |
| 18301-1112 | In distribution | |
| 18150-0617 | In distribution | |
| 18100-0516 | In distribution | |
| 18100-1017 | In distribution | |
| 18157-0815 | In distribution | |
| 18175-0716 | In distribution | |
| 18353-1112 | In distribution | |
| 18157-1114 | In distribution | |
| 18150-0916 | In distribution | |
| 18371-1112 | In distribution | |
| 18105-1216 | In distribution | |
| 18357-1112 | In distribution | |
| 18100-1215 | In distribution | |
| 18358-0708 | In distribution | |
| 18378-0910 | In distribution | |
| 18308-1112 | In distribution | |
| 18155-0714 | In distribution | |
| 18300-0100 | In distribution | |
| 18352-0708 | In distribution | |
| 18100-0716 | In distribution | |
| 18157-0914 | In distribution | |
| 18107-1405 | In distribution | |
| 18107-1407 | In distribution | |
| 18100-1016 | In distribution | |
| 18357-0910 | In distribution | |
| 18157-0714 | In distribution | |
| 18372-0910 | In distribution | |
| 18107-1211 | In distribution | |
| 18300-1615 | In distribution | |
| 18175-0916 | In distribution | |
| 18100-0617 | In distribution | |
| 18150-0614 | In distribution | |
| 18155-1015 | In distribution | |
| 18125-1207 | In distribution | |
| 18157-0615 | In distribution | |
| 18170-0917 | In distribution | |
| 18307-0708 | In distribution | |
| 18105-0815 | In distribution | |
| 18105-1115 | In distribution | |
| 18155-1215 | In distribution | |
| 18107-0915 | In distribution | |
| 18306-1112 | In distribution | |
| 18157-0514 | In distribution | |
| 18351-0708 | In distribution | |
| 18155-0914 | In distribution | |
| 18305-1112 | In distribution | |
| 18354-0708 | In distribution | |
| 18105-0916 | In distribution | |
| 18100-0816 | In distribution | |
| 18175-1016 | In distribution | |
| 18100-0515 | In distribution | |
| 18306-0506 | In distribution | |
| 18100-1217 | In distribution | |
| 18150-1117 | In distribution | |
| 18125-1210 | In distribution | |
| 18378-0506 | In distribution | |
| 18373-1112 | In distribution | |
| 18356-0910 | In distribution | |
| 18150-0516 | In distribution | |
| 18150-0517 | In distribution | |
| 18175-1216 | In distribution | |
| 18378-1112 | In distribution | |
| 18157-0915 | In distribution | |
| 18107-0715 | In distribution | |
| 18155-1016 | In distribution | |
| 18150-0716 | In distribution | |
| 18371-0910 | In distribution | |
| 18150-0817 | In distribution | |
| 18105-0615 | In distribution | |
| 18150-0717 | In distribution | |
| 18358-0506 | In distribution | |
| 18125-1205 | In distribution | |
| 18100-1411 | In distribution | |
| 18303-0910 | In distribution | |
| 18300-0200 | In distribution | |
| 18175-0516 | In distribution | |
| 18314-0300 | In distribution | |
| 18107-1209 | In distribution | |
| 18304-1112 | In distribution | |
| 18155-1014 | In distribution | |
| 18107-1210 | In distribution | |
| 18372-1112 | In distribution | |
| 18375-0708 | In distribution | |
| 18300-1617 | In distribution | |
| 18170-0816 | In distribution | |
| 18308-0708 | In distribution | |
| 18150-1114 | In distribution | |
| 18100-0915 | In distribution | |
| 18150-0914 | In distribution | |
| 18125-1206 | In distribution | |
| 18150-0615 | In distribution | |
| 18105-1015 | In distribution | |
| 18150-0515 | In distribution | |
| 18352-0910 | In distribution | |
| 18157-1014 | In distribution | |
| 18155-1116 | In distribution | |
| 18352-1112 | In distribution | |
| 18303-0708 | In distribution | |
| 18351-1112 | In distribution | |
| 18100-0616 | In distribution | |
| 18376-1112 | In distribution | |
| 18157-1214 | In distribution | |
| 18107-0815 | In distribution | |
| 18150-0814 | In distribution | |
| 18305-0506 | In distribution | |
| 18355-1112 | In distribution | |
| 18107-1208 | In distribution | |
| 18356-0708 | In distribution |
Showing 250 of 299 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Latitude-C AM™ Cervical Interbody Fusion System | Degen Medical | 1,529 |
| IdentiTi | Alphatec Spine, Inc. | 1,390 |
| Zavation | Zavation | 1,357 |
| IVA Cage Ti | Diomedical Co., Ltd. | 1,202 |
| Latitude-C Cervical Interbody Spacer System | Degen Medical | 1,185 |
| Peridot Anterior Cervical Intervertebral Body Fusion System | Gbs Commonwealth Co., Ltd. | 1,056 |
| Aleutian® Interbody Systems | VB Spine LLC | 1,017 |
| Valeo Spacer System | Sintx Technologies Inc. | 918 |
| Cascadia™ Interbody System | VB Spine LLC | 823 |
| CoRoent | Nuvasive, Inc. | 815 |
| Tyber Medical | Tyber Medical | 740 |
| Matisse Anterior Cervical Interbody Fusion Cage System | CTL Medical Corporation | 577 |
Showing 12 of 938. All products under Intervertebral Fusion Device With Bone Graft, Cervical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K181229 | 2018-09-19 |
| K142586 | 2015-05-28 |
| K110585 | 2011-03-25 |
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.