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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 the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, LP. It received FDA 510(k) clearance on 2025-04-11 under 510(k) 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. The listed applicant is Medline Industries, LP. The 510(k) number is K243888.

When did Medline UNITE® REFLEX® Hybrid Nitinol Implant System receive FDA 510(k) clearance?

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

Who is the listed applicant for Medline UNITE® REFLEX® Hybrid Nitinol Implant System?

The FDA 510(k) record lists Medline Industries, LP as the applicant. This does not by itself establish the device manufacturer.

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.

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Related Devices (Code: JDR)

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K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical ConceptsK242415TMC Compression Implant SystemTreace Medical ConceptsK240212COGNiTiON™ Staple SystemOrtho Solutions UK , Ltd.

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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