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FDA 510(k)

Medline Unite Mini Plates and Screws

K-Number: K181820 · 2018-11-01

ApplicantMedline Industries, Inc.
Decision Date2018-11-01
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Medline Unite Mini Plates and Screws is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2018-11-01 under 510(k) number K181820. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medline Unite Mini Plates and Screws?

Medline Unite Mini Plates and Screws is a medical device that received FDA 510(k) clearance on 2018-11-01. The listed applicant is Medline Industries, Inc.. The 510(k) number is K181820.

When did Medline Unite Mini Plates and Screws receive FDA 510(k) clearance?

Medline Unite Mini Plates and Screws received FDA 510(k) clearance on 2018-11-01, under 510(k) number K181820.

Who is the listed applicant for Medline Unite Mini Plates and Screws?

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

What is the FDA product code for Medline Unite Mini Plates and Screws?

The FDA product code for Medline Unite Mini Plates and Screws is HRS.

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Related Devices (Code: HRS)

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.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

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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