Lincotek Medical · Class II · Cleared Dec 5, 2025
| K-number | K250764 |
| Device name | SpineLinc Anterior Cervical Implant System |
| Applicant | Lincotek Medical |
| Product code | ODP |
| Device class | Class II |
| Decision date | Dec 5, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3080 |
The SpineLinc Anterior Cervical Implant System is a cervical interbody fusion device intended for skeletally mature patients with degenerative disc disease of the cervical spine (C2-T1) at one or two levels who have failed at least six weeks of non-operative treatment. The system consists of a cervical spacer body (filled with autograft or allogeneic bone), a cervical plate, screws, and a locking clip, manufactured from titanium alloy or stainless steel and provided sterile as single-use kits.
Device sizing, geometry, technological characteristics, and materials are similar to the predicate Hedron Cervical Spacers (K191243). The spacer body is compatible with the SpineLinc Plates and Screws and may be implanted in various configurations to accommodate patient anatomy. Implants are manufactured from titanium alloy per ASTM F136 or ASTM F3001; instruments are medical-grade stainless steel per ASTM F899.
Static and Dynamic Axial Compression per ASTM F2077; Static and Dynamic Compression Shear per ASTM F2077; Static and Dynamic Torsion per ASTM F2077; Expulsion and Subsidence per ASTM F2267; MR Compatibility assessment utilizing simulation of ASTM 2182-19e2.
The subject device is substantially equivalent to the Globus Medical HEDRON Cervical Spacers (K191243) based on similar indications for use, device sizing, geometry, technological characteristics, and materials. Performance testing demonstrates comparable mechanical properties to predicate devices, supporting substantial equivalence.
View the full FDA submission: accessdata.fda.gov