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FDA 510(k)

Medline UNITE® Digital Fusion Screw System

K-Number: K211944 · 2021-07-22

ApplicantMedline Industries, Inc.
Decision Date2021-07-22
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Medline UNITE® Digital Fusion Screw System is a medical device manufactured by Medline Industries, Inc.. It received FDA 510(k) clearance on 2021-07-22 under approval number K211944. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medline UNITE® Digital Fusion Screw System?

Medline UNITE® Digital Fusion Screw System is a medical device that received FDA 510(k) clearance on 2021-07-22. It is manufactured by Medline Industries, Inc.. The 510(k) number is K211944.

When was Medline UNITE® Digital Fusion Screw System approved by the FDA?

Medline UNITE® Digital Fusion Screw System received FDA 510(k) clearance on 2021-07-22, under approval number K211944.

What company makes Medline UNITE® Digital Fusion Screw System?

Medline UNITE® Digital Fusion Screw System is manufactured by Medline Industries, Inc..

What is the FDA product code for Medline UNITE® Digital Fusion Screw System?

The FDA product code for Medline UNITE® Digital Fusion Screw System is HWC. This falls under the Cardiovascular category.

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 NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07557147 Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-Monitor NOT_YET_RECRUITING NCT07586163 Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency ACTIVE_NOT_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07578142 AcceXible Speech-Based Screening for Depression and Anxiety in University Students (UAQ, Mexico) NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41734979 Strategies to Increase Patients' Adherence to Digital Therapeutics for Musculoskeletal Diseases: A Narrative Review. Yonsei medical journal (2026) PMID: 41491965 From stones to system: integrating kidney stones disease into the cardiovascular-kidney-metabolic continuum. Current opinion in nephrology and hypertension (2026) PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025) PMID: 40845310 Should Digital Interventions for HIV Self-Testing Be Regulated with World Health Organization Prequalification? JMIR mHealth and uHealth (2025)

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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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