UNiTi ACDF Implant System— 510(k) K200301

Substantially Equivalent

Pressio, Inc.

FDA 510(k) clearance K200301 for UNiTi ACDF Implant System, Substantially Equivalent on 2021-02-03. Applicant: Pressio, Inc..

Clearance details

Applicant: Pressio, Inc.
Product code: Code PHQ
Advisory panel: Orthopedic
Date received: 2020-02-06
Decision date: 2021-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

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