VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left— 510(k) K193580

Substantially Equivalent

Orthosensor, Inc.

FDA 510(k) clearance K193580 for VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left, Substantially Equivalent on 2020-04-01. Applicant: Orthosensor, Inc..

Clearance details

Applicant: Orthosensor, Inc.
Product code: Code ONN
Advisory panel: Neurology
Date received: 2019-12-23
Decision date: 2020-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dania Beach, FL, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.