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)

Medline UNITE® REFLEX® Hybrid Nitinol Implant System

K-Number: K243888 · 2025-04-11

ApplicantMedline Industries, LP
Decision Date2025-04-11
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Medline UNITE® REFLEX® Hybrid Nitinol Implant System is a medical device manufactured by Medline Industries, LP. It received FDA 510(k) clearance on 2025-04-11 under approval number K243888. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medline UNITE® REFLEX® Hybrid Nitinol Implant System?

Medline UNITE® REFLEX® Hybrid Nitinol Implant System is a medical device that received FDA 510(k) clearance on 2025-04-11. It is manufactured by Medline Industries, LP. The 510(k) number is K243888.

When was Medline UNITE® REFLEX® Hybrid Nitinol Implant System approved by the FDA?

Medline UNITE® REFLEX® Hybrid Nitinol Implant System received FDA 510(k) clearance on 2025-04-11, under approval number K243888.

What company makes Medline UNITE® REFLEX® Hybrid Nitinol Implant System?

Medline UNITE® REFLEX® Hybrid Nitinol Implant System is manufactured by Medline Industries, LP.

What is the FDA product code for Medline UNITE® REFLEX® Hybrid Nitinol Implant System?

The FDA product code for Medline UNITE® REFLEX® Hybrid Nitinol Implant System is JDR.

Related Clinical Trials

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 NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT04414280 The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs 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 Medline Industries, LP

K220365Gemini Sterilization Wrap K221360Medline UNITE® Medial Malleolus Peg Plate System K220333Medline Orbis LVL 3 Surgical Gown K214108Medline Orbis Chemo Surgical Gown K220511Medline UNITE IM Fibula Implant K213567Medline UNITE Calcaneal Fracture Plating System

View all 29 devices →

Related Devices (Code: JDR)

K161426NeoSpan Compression Staple Impant w/instrumentsIn2bones USA, LLC K160813EasyStepStryker GmbH K153622First Ray Internal Bone Staple SystemFirst Ray, LLC K153770OS2(R)-VP Varisation StapleIn2bones Sas K153395OS2-C Compression StapleIn2bones Sas K153129dynaMX Tabbed StapleMx Orthopedics, Corp.

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.

↑