Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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 the device name listed in this FDA 510(k) record. The listed applicant is Orthosensor, Inc.. It received FDA 510(k) clearance on 2018-06-07 under 510(k) 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. The listed applicant is Orthosensor, Inc.. The 510(k) number is K180459.

When did VERASENSE for Zimmer Biomet Persona receive FDA 510(k) clearance?

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

Who is the listed applicant for VERASENSE for Zimmer Biomet Persona?

The FDA 510(k) record lists Orthosensor, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05391828Persona MC vs PS RCT With ROSARECRUITINGNCT06089291Persona IQ Cohort StudyACTIVE_NOT_RECRUITING

Other records listing Orthosensor, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200587VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for ShoulderK200665VERASENSE for Stryker TriathlonK193580VERASENSE 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 LeftK150372VERASENSE Knee System

Related Devices (Code: ONN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262253Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)Orthalign, Inc.K253507Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeOrthalign, Inc.K252524Quadsense (Quadsense and Quadsense Pro)Eventum Orthopaedics, Ltd.K241298QUADSENSEEventum Orthopaedics, Ltd.K242616Lantern® HipOrthalign, 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.

↑