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FDA 510(k)

Medline UNITE® Snap-Off Screws

K-Number: K170782 · 2017-08-18

ApplicantMedline Industries, Inc.
Decision Date2017-08-18
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Medline UNITE® Snap-Off 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 2017-08-18 under 510(k) number K170782. 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® Snap-Off Screws?

Medline UNITE® Snap-Off Screws is a medical device that received FDA 510(k) clearance on 2017-08-18. The listed applicant is Medline Industries, Inc.. The 510(k) number is K170782.

When did Medline UNITE® Snap-Off Screws receive FDA 510(k) clearance?

Medline UNITE® Snap-Off Screws received FDA 510(k) clearance on 2017-08-18, under 510(k) number K170782.

Who is the listed applicant for Medline UNITE® Snap-Off 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® Snap-Off Screws?

The FDA product code for Medline UNITE® Snap-Off Screws 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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