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

FDA 510(k)

Lucero Medical Cervical Cage System

K-Number: K200549 · 2020-12-16

ApplicantLucero Medical, LLC
Decision Date2020-12-16
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Lucero Medical Cervical Cage System is a medical device manufactured by Lucero Medical, LLC. It received FDA 510(k) clearance on 2020-12-16 under approval number K200549. 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 Lucero Medical Cervical Cage System?

Lucero Medical Cervical Cage System is a medical device that received FDA 510(k) clearance on 2020-12-16. It is manufactured by Lucero Medical, LLC. The 510(k) number is K200549.

When was Lucero Medical Cervical Cage System approved by the FDA?

Lucero Medical Cervical Cage System received FDA 510(k) clearance on 2020-12-16, under approval number K200549.

What company makes Lucero Medical Cervical Cage System?

Lucero Medical Cervical Cage System is manufactured by Lucero Medical, LLC.

What is the FDA product code for Lucero Medical Cervical Cage System?

The FDA product code for Lucero Medical Cervical Cage System is ODP.

Related Clinical Trials

NCT01143558 Searching for Persistence of Infection in Lyme Disease COMPLETED NCT07137455 EDEN Intracardiac Electrogram Recording and Classifying System ENROLLING_BY_INVITATION NCT01174108 Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells RECRUITING NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT05701917 DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis RECRUITING NCT05754281 The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

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.

↑