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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anterior Staple As Supplemental Fixation For Fusion
510(k) Number K200301
Device Name UNiTi ACDF Implant System
Applicant
Pressio, Inc.
14785 Omicron Dr., Suite 100
San Antonio,  TX  78245
Applicant Contact Joe Ritz
Correspondent
Empirical Testing Corp
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Nathan Wright
Regulation Number888.3060
Classification Product Code
PHQ  
Date Received02/06/2020
Decision Date 02/03/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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