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FDA 510(k)

Medline UNITE® REFLEX® Nitinol Staple System

K-Number: K231885 · 2023-08-09

ApplicantMedline Industries, LP
Decision Date2023-08-09
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Medline UNITE® REFLEX® Nitinol Staple 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 2023-08-09 under 510(k) number K231885. 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® Nitinol Staple System?

Medline UNITE® REFLEX® Nitinol Staple System is a medical device that received FDA 510(k) clearance on 2023-08-09. The listed applicant is Medline Industries, LP. The 510(k) number is K231885.

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

Medline UNITE® REFLEX® Nitinol Staple System received FDA 510(k) clearance on 2023-08-09, under 510(k) number K231885.

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

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

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Related Devices (Code: JDR)

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.

K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical ConceptsK242415TMC Compression Implant SystemTreace Medical Concepts

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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