UNiTi ACDF Implant System

Anterior Staple As Supplemental Fixation For Fusion

Pressio, Inc.

The following data is part of a premarket notification filed by Pressio, Inc. with the FDA for Uniti Acdf Implant System.

Pre-market Notification Details

Device IDK200301
510k NumberK200301
Device Name:UNiTi ACDF Implant System
ClassificationAnterior Staple As Supplemental Fixation For Fusion
Applicant Pressio, Inc. 14785 Omicron Drive, Suite 100 San Antonio,  TX  78245
ContactJoe Ritz
CorrespondentNathan Wright
Empirical Testing Corp. 4628 Northpark Drive Colorado Springs,  CO  80918
Product CodePHQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-06
Decision Date2021-02-03

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