Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VERASENSE for Zimmer Biomet Persona

K-Number: K180459 · 2018-06-07

ApplicantOrthosensor, Inc.
Decision Date2018-06-07
Product CodeONN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

VERASENSE for Zimmer Biomet Persona is a medical device manufactured by Orthosensor, Inc.. It received FDA 510(k) clearance on 2018-06-07 under approval number K180459. The device is classified under product code ONN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERASENSE for Zimmer Biomet Persona?

VERASENSE for Zimmer Biomet Persona is a medical device that received FDA 510(k) clearance on 2018-06-07. It is manufactured by Orthosensor, Inc.. The 510(k) number is K180459.

When was VERASENSE for Zimmer Biomet Persona approved by the FDA?

VERASENSE for Zimmer Biomet Persona received FDA 510(k) clearance on 2018-06-07, under approval number K180459.

What company makes VERASENSE for Zimmer Biomet Persona?

VERASENSE for Zimmer Biomet Persona is manufactured by Orthosensor, Inc..

What is the FDA product code for VERASENSE for Zimmer Biomet Persona?

The FDA product code for VERASENSE for Zimmer Biomet Persona is ONN.

Related Clinical Trials

NCT06089291 Persona IQ Cohort Study ENROLLING_BY_INVITATION NCT04984291 Zimmer Biomet Shoulder Arthroplasty PMCF RECRUITING NCT07485829 Zimmer Biomet-RibFix Titan RECRUITING NCT06388993 Marrow Cellution™ vs. Traditional BMA Harvest Project RECRUITING

Other Devices by Orthosensor, Inc.

K150372VERASENSE Knee System K200587VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder K200665VERASENSE for Stryker Triathlon K193580VERASENSE 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

Related Devices (Code: ONN)

K150372VERASENSE Knee SystemOrthosensor, Inc. K162237XO1 Knee Balancing SystemXpandortho, Inc. K200587VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for ShoulderOrthosensor, Inc. K200665VERASENSE for Stryker TriathlonOrthosensor, Inc. K193580VERASENSE 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 LeftOrthosensor, Inc. K220830TrueBalance™ Surgical SystemThese Three Medical, LLC

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.

↑