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FDA 510(k)

SpineLinc Anterior Cervical Implant System

K-Number: K250764 · 2025-12-05

ApplicantLincotek Medical
Decision Date2025-12-05
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SpineLinc Anterior Cervical Implant System is a medical device manufactured by Lincotek Medical. It received FDA 510(k) clearance on 2025-12-05 under approval number K250764. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SpineLinc Anterior Cervical Implant System?

SpineLinc Anterior Cervical Implant System is a medical device that received FDA 510(k) clearance on 2025-12-05. It is manufactured by Lincotek Medical. The 510(k) number is K250764.

When was SpineLinc Anterior Cervical Implant System approved by the FDA?

SpineLinc Anterior Cervical Implant System received FDA 510(k) clearance on 2025-12-05, under approval number K250764.

What company makes SpineLinc Anterior Cervical Implant System?

SpineLinc Anterior Cervical Implant System is manufactured by Lincotek Medical.

What is the FDA product code for SpineLinc Anterior Cervical Implant System?

The FDA product code for SpineLinc Anterior Cervical Implant System is ODP.

Related Clinical Trials

NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT06642935 A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss ACTIVE_NOT_RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT05855135 Assessment of Combined CCM and ICD Device in HFrEF ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Lincotek Medical

K252081SportLinc Syndesmosis Device

Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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