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FDA 510(k)

Medline UNITE Jones Fracture Screw System

K-Number: K201319 · 2020-06-17

ApplicantMedline Industires, Inc.
Decision Date2020-06-17
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Medline UNITE Jones Fracture Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industires, Inc.. It received FDA 510(k) clearance on 2020-06-17 under 510(k) number K201319. 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 Jones Fracture Screw System?

Medline UNITE Jones Fracture Screw System is a medical device that received FDA 510(k) clearance on 2020-06-17. The listed applicant is Medline Industires, Inc.. The 510(k) number is K201319.

When did Medline UNITE Jones Fracture Screw System receive FDA 510(k) clearance?

Medline UNITE Jones Fracture Screw System received FDA 510(k) clearance on 2020-06-17, under 510(k) number K201319.

Who is the listed applicant for Medline UNITE Jones Fracture Screw System?

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

What is the FDA product code for Medline UNITE Jones Fracture Screw System?

The FDA product code for Medline UNITE Jones Fracture Screw System is HWC. This falls under the Cardiovascular category.

Other records listing Medline Industires, Inc. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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