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FDA 510(k)

UNiTi ACDF Implant System

K-Number: K200301 · 2021-02-03

ApplicantPressio, Inc.
Decision Date2021-02-03
Product CodePHQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNiTi ACDF Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Pressio, Inc.. It received FDA 510(k) clearance on 2021-02-03 under 510(k) number K200301. The device is classified under product code PHQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNiTi ACDF Implant System?

UNiTi ACDF Implant System is a medical device that received FDA 510(k) clearance on 2021-02-03. The listed applicant is Pressio, Inc.. The 510(k) number is K200301.

When did UNiTi ACDF Implant System receive FDA 510(k) clearance?

UNiTi ACDF Implant System received FDA 510(k) clearance on 2021-02-03, under 510(k) number K200301.

Who is the listed applicant for UNiTi ACDF Implant System?

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

What is the FDA product code for UNiTi ACDF Implant System?

The FDA product code for UNiTi ACDF Implant System is PHQ.

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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