Plif Interbody System
The PLIF TiPEEK interbody is a PEEK lumbar fusion cage with plasma-sprayed commercially pure titanium on its upper and lower surfaces. The open architecture holds autogenous bone graft.…
The PLIF TiPEEK interbody is a PEEK lumbar fusion cage with plasma-sprayed commercially pure titanium on its upper and lower surfaces. The open architecture holds autogenous bone graft. Teeth on the exterior engage the adjacent vertebrae to resist migration after placement.
Use is intended for skeletally mature patients with degenerative disc disease at one or two contiguous levels from L2 to S1 after six months of nonoperative treatment. The implant is used with supplemental fixation cleared for the thoracolumbar spine.
Listed Item
PLIF TiPEEK 26mm x 10mm x 11mm x 8 deg
Configuration and Approach
The Tyber range includes different footprints, heights and lordotic angles, in plain PEEK or titanium-coated PEEK versions. The PLIF configuration is used through a posterior lumbar approach. Cervical implants in the same broader system have separate indications and are not the lumbar cage described here.
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 | Tyber Medical, 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) | K130573 |
| Record published | 2019-11-12 |
| Record revised | 2025-08-15 (version 4) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20-502-P26888-S | In distribution | |
| 20-502-P2611810-S | In distribution | |
| 20-502-P241388-S | In distribution | |
| 20-502-P267810-S | In distribution | |
| 20-502-P268810-S | 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 |
|---|---|
| K182284 | 2019-01-18 |
| K180590 | 2018-07-06 |
| K172185 | 2017-12-21 |
| K130573 | 2013-09-30 |
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.