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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 a medical device manufactured by Pressio, Inc.. It received FDA 510(k) clearance on 2021-02-03 under approval 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. It is manufactured by Pressio, Inc.. The 510(k) number is K200301.

When was UNiTi ACDF Implant System approved by the FDA?

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

What company makes UNiTi ACDF Implant System?

UNiTi ACDF Implant System is manufactured by Pressio, Inc..

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

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

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Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

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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