LnK Cervical Interbody Fusion Cage System
LnK Cervical Interbody Fusion Cage System uses PEEK-OPTIMA LT1 spacers with unalloyed tantalum marker pins. The spacers are placed between cervical vertebrae to support interbody fusion,…
LnK Cervical Interbody Fusion Cage System uses PEEK-OPTIMA LT1 spacers with unalloyed tantalum marker pins. The spacers are placed between cervical vertebrae to support interbody fusion, while the markers provide radiographic visibility.
Different sizes and configurations accommodate vertebral anatomy. The cages are used with autograft bone and require supplemental fixation as part of the cervical fusion construct.
Listed Item
L&K Biomed ACIF PEEK Cage (STERILE)15*15*10mm 1EA
Cervical Use
The system is intended for a single disc level between C3 and C7 in skeletally mature patients with cervical degenerative disc disease and accompanying radicular symptoms. The specified treatment pathway follows at least six weeks of nonoperative care.
7manufacturers in China registered for this device type
216catalogue numbers in this listing
5510(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 | L&K Biomed Co., Ltd., South Korea |
|---|---|
| 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, Exporter |
| 510(k) | K151677 |
| Record published | 2015-09-24 |
| Record revised | 2020-02-24 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5208-1217 | In distribution | |
| 5107-1519 | In distribution | |
| 5210-1519 | In distribution | |
| 5110-1515S | In distribution | |
| 5108-1414S | In distribution | |
| 5107-1519S | In distribution | |
| 5105-1217S | In distribution | |
| 5106-1419S | In distribution | |
| 5107-1414S | In distribution | |
| 5105-1515 | In distribution | |
| 5106-1517 | In distribution | |
| 5206-1414 | In distribution | |
| 5105-1217 | In distribution | |
| 5110-1315S | In distribution | |
| 5109-1419 | In distribution | |
| 5205-1515 | In distribution | |
| 5108-1517S | In distribution | |
| 5205-1214 | In distribution | |
| 5110-1315S | In distribution | |
| 5107-1214S | In distribution | |
| 5110-1517S | In distribution | |
| 5107-1315S | In distribution | |
| 5110-1214S | In distribution | |
| 5108-1419S | In distribution | |
| 5208-1519 | In distribution | |
| 5106-1515S | In distribution | |
| 5209-1414 | In distribution | |
| 5108-1417S | In distribution | |
| 5110-1419S | In distribution | |
| 5107-1515 | In distribution | |
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| 5208-1214 | In distribution | |
| 5108-1515S | In distribution | |
| 5108-1315 | In distribution | |
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| 5209-1519 | In distribution | |
| 5108-1515 | In distribution | |
| 5206-1419 | In distribution | |
| 5207-1414 | In distribution | |
| 5106-1315S | In distribution | |
| 5207-1519 | In distribution | |
| 5208-1517 | In distribution | |
| 5110-1414 | In distribution | |
| 5109-1519 | In distribution | |
| 5208-1417 | In distribution | |
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| 5206-1417 | In distribution | |
| 5109-1315S | In distribution | |
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| 5210-1417 | In distribution | |
| 5107-1214S | In distribution | |
| 5107-1417S | In distribution | |
| 5205-1315 | In distribution | |
| 5209-1217 | In distribution | |
| 5105-1419S | In distribution | |
| 5105-1517 | In distribution | |
| 5208-1515 | In distribution | |
| 5109-1517S | In distribution | |
| 5109-1214 | In distribution | |
| 5110-1414S | In distribution | |
| 5106-1519 | In distribution | |
| 5108-1217 | 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 |
|---|---|
| K262489 | 2026-08-18 |
| K260840 | 2026-05-16 |
| K151677 | 2015-07-15 |
| K143360 | 2015-04-03 |
| K120840 | 2012-05-24 |
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.