Fortilink-TS IBF System With TETRAfuse 3d Technology
Fortilink-TS Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 11mm (H), 22mm (L), 6° Lordosis
7manufacturers in China registered for this device type
22catalogue numbers in this listing
1510(k) clearance
1recall
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 | Pioneer Surgical Technology, 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 | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Record published | 2017-10-30 |
| Record revised | 2026-02-09 (version 8) |
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 |
| Distribution end date | 2021-02-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 65-TS-10-26 | 10mm (H), 26mm (L) | Withdrawn |
| 65-TS-11-22-6L | 11mm (H), 22mm (L), 6° Lordosis | Withdrawn |
| 65-TS-8-26-6L | 8mm (H), 26mm (L), 6° Lordosis | Withdrawn |
| 65-TS-13-26 | 13mm (H), 26mm (L) | Withdrawn |
| 65-TS-14-22-6L | 14mm (H), 22mm (L), 6° Lordosis | Withdrawn |
| 65-TS-16-26-6L | 16mm (H), 26mm (L), 6° Lordosis | Withdrawn |
| 65-TS-8-26 | 8mm (H), 26mm (L) | Withdrawn |
| 65-TS-9-22-6L | 9mm (H), 22mm (L), 6° Lordosis | Withdrawn |
| 65-TS-16-26 | 16mm (H), 26mm (L) | Withdrawn |
| 65-TS-9-22 | 9mm (H), 22mm (L) | Withdrawn |
| 65-TS-15-22-6L | 15mm (H), 22mm (L), 6° Lordosis | Withdrawn |
| 65-TS-14-26 | 14mm (H), 26mm (L) | Withdrawn |
| 65-TS-16-22-6L | 16mm (H), 22mm (L), 6° Lordosis | Withdrawn |
| 65-TS-12-22 | 12mm (H), 22mm (L) | Withdrawn |
| 65-TS-12-26 | 12mm (H), 26mm (L) | Withdrawn |
| 65-TS-13-26-6L | 13mm (H), 26mm (L), 6° Lordosis | Withdrawn |
| 65-TS-12-26-6L | 12mm (H), 26mm (L), 6° Lordosis | Withdrawn |
| 65-TS-14-26-6L | 14mm (H), 26mm (L), 6° Lordosis | Withdrawn |
| 65-TS-9-26 | 9mm (H), 26mm (L) | Withdrawn |
| 65-TS-11-26 | 11mm (H), 26mm (L) | Withdrawn |
| 65-TS-15-26 | 15mm (H), 26mm (L) | Withdrawn |
| 65-TS-10-22 | 10mm (H), 22mm (L) | Withdrawn |
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 |
|---|---|
| K133623 | 2014-02-10 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-10-07 | Class II | Labeling False and Misleading | As the result of a recent internal review of regulatory documents, we have determined that the 10 mm x 12 mm Webless C-Plus implants were incorrectly documented as meeting the requirement for labeling as a partial Vertebral Body Replacement | 1906 | 2014-02-26 |
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.