TiWave C Cervical Cage System
TiWave C is a porous titanium cervical interbody cage made by additive manufacturing. It is placed between cervical vertebrae as part of interbody fusion, with implant heights and lengths…
TiWave C is a porous titanium cervical interbody cage made by additive manufacturing. It is placed between cervical vertebrae as part of interbody fusion, with implant heights and lengths selected for the patient’s anatomy.
The Grade 23 titanium implant is used with autograft and/or allogeneic cancellous or corticocancellous bone graft. Supplemental fixation is required as part of the fusion construct.
Listed Item
Cervical Cage, anatomic, 19mm x 14mm, 10mm, 14 degrees, extra tapered
Supply and Instruments
The implants are supplied sterile. Separate system instruments are stainless steel and assist their placement. The cage is intended for skeletally mature patients at one or two adjacent cervical levels from C2 to T1 following at least six weeks of nonoperative treatment.
7manufacturers in China registered for this device type
232catalogue numbers in this listing
2510(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 | Kalitec Direct, LLC, United States |
|---|---|
| FDA product code | ODP |
| Device type | Intervertebral Fusion Device With Bone Graft, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| 510(k) | K180401 |
| Record published | 2018-08-31 |
| Record revised | 2025-07-14 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20-CAX-6412 | In distribution | |
| 20-CAN-6407 | In distribution | |
| 20-CFT-7307 | In distribution | |
| 20-CFT-6408 | In distribution | |
| 20-CFX-9408 | In distribution | |
| 20-CAT-3206 | In distribution | |
| 20-CFN-3205 | In distribution | |
| 20-CAT-7308 | In distribution | |
| 20-CFX-6412 | In distribution | |
| 20-CAX-6411 | In distribution | |
| 20-CAX-9410 | In distribution | |
| 20-CFN-5206 | In distribution | |
| 20-CFX-6408 | In distribution | |
| 20-CFX-3205 | In distribution | |
| 20-CAN-6411 | In distribution | |
| 20-CAX-3212 | In distribution | |
| 20-CFT-6409 | In distribution | |
| 20-CFT-3211 | In distribution | |
| 20-CAX-7308 | In distribution | |
| 20-CFN-7309 | In distribution | |
| 20-CFN-7310 | In distribution | |
| 20-CAT-7306 | In distribution | |
| 20-CAN-6409 | In distribution | |
| 20-CFN-6405 | In distribution | |
| 20-CFN-3206 | In distribution | |
| 20-CFT-9412 | In distribution | |
| 20-CFT-3205 | In distribution | |
| 20-CAX-9412 | In distribution | |
| 20-CAN-3210 | In distribution | |
| 20-CFX-9406 | In distribution | |
| 20-CFX-9409 | In distribution | |
| 20-CAT-6406 | In distribution | |
| 20-CFN-9410 | In distribution | |
| 20-CFT-9410 | In distribution | |
| 20-CFX-5210 | In distribution | |
| 20-CFN-6408 | In distribution | |
| 20-CAX-5207 | In distribution | |
| 20-CAT-5211 | In distribution | |
| 20-CAN-6406 | In distribution | |
| 20-CFX-6410 | In distribution | |
| 20-CAT-9411 | In distribution | |
| 20-CFT-9407 | In distribution | |
| 20-CFX-5209 | In distribution | |
| 20-CAN-3205 | In distribution | |
| 20-CAX-5212 | In distribution | |
| 20-CFN-5209 | In distribution | |
| 20-CAX-6407 | In distribution | |
| 20-CAN-3206 | In distribution | |
| 20-CAT-7309 | In distribution | |
| 20-CFX-3212 | In distribution | |
| 20-CFN-6406 | In distribution | |
| 20-CAN-7312 | In distribution | |
| 20-CAT-7311 | In distribution | |
| 20-CFN-3209 | In distribution | |
| 20-CAX-9407 | In distribution | |
| 20-CAX-5206 | In distribution | |
| 20-CAT-6410 | In distribution | |
| 20-CFX-7310 | In distribution | |
| 20-CAN-5212 | In distribution | |
| 20-CFN-6412 | In distribution | |
| 20-CFX-6406 | In distribution | |
| 20-CFX-6411 | In distribution | |
| 20-CFT-5208 | In distribution | |
| 20-CFX-9412 | In distribution | |
| 20-CAT-7305 | In distribution | |
| 20-CFN-9405 | In distribution | |
| 20-CFN-7312 | In distribution | |
| 20-CFX-9411 | In distribution | |
| 20-CAT-5208 | In distribution | |
| 20-CAN-5208 | In distribution | |
| 20-CAN-9405 | In distribution | |
| 20-CAX-5210 | In distribution | |
| 20-CAX-3211 | In distribution | |
| 20-CAT-5209 | In distribution | |
| 20-CAN-3212 | In distribution | |
| 20-CFT-7308 | In distribution | |
| 20-CFX-5208 | In distribution | |
| 20-CFX-5206 | In distribution | |
| 20-CFT-6405 | In distribution | |
| 20-CFN-9412 | In distribution | |
| 20-CFN-9407 | In distribution | |
| 20-CFT-9411 | In distribution | |
| 20-CAX-6409 | In distribution | |
| 20-CAN-5206 | In distribution | |
| 20-CFN-6407 | In distribution | |
| 20-CAX-6406 | In distribution | |
| 20-CFN-5205 | In distribution | |
| 20-CFN-9409 | In distribution | |
| 20-CAN-5211 | In distribution | |
| 20-CAT-9407 | In distribution | |
| 20-CAN-9406 | In distribution | |
| 20-CFT-5210 | In distribution | |
| 20-CAN-5205 | In distribution | |
| 20-CAX-3206 | In distribution | |
| 20-CAX-7312 | In distribution | |
| 20-CFT-5205 | In distribution | |
| 20-CAN-6408 | In distribution | |
| 20-CFT-3212 | In distribution | |
| 20-CAN-6410 | In distribution | |
| 20-CFT-3210 | In distribution | |
| 20-CFX-5212 | In distribution | |
| 20-CFX-3211 | In distribution | |
| 20-CAT-7307 | In distribution | |
| 20-CFT-5207 | In distribution | |
| 20-CFN-7307 | In distribution | |
| 20-CAX-5211 | In distribution | |
| 20-CAT-3205 | In distribution | |
| 20-CFX-7311 | In distribution | |
| 20-CFX-7312 | In distribution | |
| 20-CAN-3207 | In distribution | |
| 20-CFX-7309 | In distribution | |
| 20-CAN-5209 | In distribution | |
| 20-CFN-7308 | In distribution | |
| 20-CAT-5205 | In distribution | |
| 20-CFN-3207 | In distribution | |
| 20-CFX-5211 | In distribution | |
| 20-CAT-6407 | In distribution | |
| 20-CAT-9405 | In distribution | |
| 20-CFN-7305 | In distribution | |
| 20-CAX-3205 | In distribution | |
| 20-CAX-9411 | In distribution | |
| 20-CAT-9409 | In distribution | |
| 20-CAN-9407 | In distribution | |
| 20-CAX-5205 | In distribution | |
| 20-CAX-9406 | In distribution | |
| 20-CFT-5206 | In distribution | |
| 20-CAN-9411 | In distribution | |
| 20-CFX-3210 | In distribution | |
| 20-CFN-5210 | In distribution | |
| 20-CAN-6412 | In distribution | |
| 20-CFT-6412 | In distribution | |
| 20-CAX-7306 | In distribution | |
| 20-CAX-7311 | In distribution | |
| 20-CAT-9410 | In distribution | |
| 20-CFN-9408 | In distribution | |
| 20-CAT-3210 | In distribution | |
| 20-CAX-6410 | In distribution | |
| 20-CAX-5209 | In distribution | |
| 20-CFN-6411 | In distribution | |
| 20-CAT-9406 | In distribution | |
| 20-CAT-6412 | In distribution | |
| 20-CFX-6407 | In distribution | |
| 20-CFT-3206 | In distribution | |
| 20-CFN-9411 | In distribution | |
| 20-CAX-9409 | In distribution | |
| 20-CAN-7307 | In distribution | |
| 20-CAX-3208 | In distribution | |
| 20-CFN-6409 | In distribution | |
| 20-CFX-9410 | In distribution | |
| 20-CAN-3211 | In distribution | |
| 20-CAN-3209 | In distribution | |
| 20-CAX-3210 | In distribution | |
| 20-CFT-6411 | In distribution | |
| 20-CAN-9408 | In distribution | |
| 20-CFX-3206 | In distribution | |
| 20-CAT-6409 | In distribution | |
| 20-CAX-7309 | In distribution | |
| 20-CAX-3209 | In distribution | |
| 20-CAN-7311 | In distribution | |
| 20-CAX-7310 | In distribution | |
| 20-CFX-3209 | In distribution | |
| 20-CAN-9412 | In distribution | |
| 20-CFT-7305 | In distribution | |
| 20-CAT-3209 | In distribution | |
| 20-CAN-5207 | In distribution | |
| 20-CAT-7310 | In distribution | |
| 20-CFT-5211 | In distribution | |
| 20-CAX-7307 | In distribution | |
| 20-CAT-5212 | In distribution | |
| 20-CFX-7306 | In distribution | |
| 20-CFX-5205 | In distribution | |
| 20-CAT-6411 | In distribution | |
| 20-CAX-5208 | In distribution | |
| 20-CAN-7308 | In distribution | |
| 20-CFT-3207 | In distribution | |
| 20-CAT-6405 | In distribution | |
| 20-CAT-3207 | In distribution | |
| 20-CAT-5210 | In distribution | |
| 20-CFT-7309 | In distribution | |
| 20-CAN-7306 | In distribution | |
| 20-CFT-5209 | In distribution | |
| 20-CFT-9406 | In distribution | |
| 20-CFX-3208 | In distribution | |
| 20-CAX-6408 | In distribution | |
| 20-CFN-6410 | In distribution | |
| 20-CFT-9408 | In distribution | |
| 20-CAN-7305 | In distribution | |
| 20-CFN-5212 | In distribution | |
| 20-CFT-7310 | In distribution | |
| 20-CFN-5208 | In distribution | |
| 20-CAT-5206 | In distribution | |
| 20-CAN-3208 | In distribution | |
| 20-CFN-7306 | In distribution | |
| 20-CFN-3212 | In distribution | |
| 20-CAN-9409 | In distribution | |
| 20-CAT-7312 | In distribution | |
| 20-CFN-5207 | In distribution | |
| 20-CFT-5212 | In distribution | |
| 20-CAT-6408 | In distribution | |
| 20-CAX-9408 | In distribution | |
| 20-CFX-7308 | In distribution | |
| 20-CAT-3211 | In distribution | |
| 20-CAX-3207 | In distribution | |
| 20-CFN-5211 | In distribution | |
| 20-CFN-9406 | In distribution | |
| 20-CFT-7311 | In distribution | |
| 20-CAT-9412 | In distribution | |
| 20-CAT-3212 | In distribution | |
| 20-CAN-9410 | In distribution | |
| 20-CFN-3211 | In distribution | |
| 20-CAN-6405 | In distribution | |
| 20-CAN-5210 | In distribution | |
| 20-CFN-7311 | In distribution | |
| 20-CFT-6407 | In distribution | |
| 20-CFX-7307 | In distribution | |
| 20-CFT-3208 | In distribution | |
| 20-CFN-3210 | In distribution | |
| 20-CAN-7310 | In distribution | |
| 20-CFT-9409 | In distribution | |
| 20-CAT-9408 | In distribution | |
| 20-CFT-3209 | In distribution | |
| 20-CAT-3208 | In distribution | |
| 20-CAN-7309 | In distribution | |
| 20-CFT-6406 | In distribution | |
| 20-CFT-7306 | In distribution | |
| 20-CFX-3207 | In distribution | |
| 20-CFT-6410 | In distribution | |
| 20-CFT-7312 | In distribution | |
| 20-CFN-3208 | In distribution | |
| 20-CAT-5207 | In distribution | |
| 20-CFT-9405 | In distribution | |
| 20-CFX-5207 | In distribution |
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 |
|---|---|
| K180401 | 2018-06-14 |
| K133815 | 2014-04-16 |
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.