Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Lincotek Medical. It received FDA 510(k) clearance on 2025-12-05 under 510(k) 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. The listed applicant is Lincotek Medical. The 510(k) number is K250764.

When did SpineLinc Anterior Cervical Implant System receive FDA 510(k) clearance?

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

Who is the listed applicant for SpineLinc Anterior Cervical Implant System?

The FDA 510(k) record lists Lincotek Medical as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATION

Other records listing Lincotek Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252081SportLinc Syndesmosis Device

Related Devices (Code: ODP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K260850OSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.

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.

↑