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FDA 510(k)

Medline UNITE® Digital Fusion Screw System

K-Number: K211944 · 2021-07-22

ApplicantMedline Industries, Inc.
Decision Date2021-07-22
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Medline UNITE® Digital Fusion Screw System 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 2021-07-22 under 510(k) number K211944. 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® Digital Fusion Screw System?

Medline UNITE® Digital Fusion Screw System is a medical device that received FDA 510(k) clearance on 2021-07-22. The listed applicant is Medline Industries, Inc.. The 510(k) number is K211944.

When did Medline UNITE® Digital Fusion Screw System receive FDA 510(k) clearance?

Medline UNITE® Digital Fusion Screw System received FDA 510(k) clearance on 2021-07-22, under 510(k) number K211944.

Who is the listed applicant for Medline UNITE® Digital Fusion Screw System?

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® Digital Fusion Screw System?

The FDA product code for Medline UNITE® Digital Fusion Screw System is HWC. This falls under the Cardiovascular category.

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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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