Orthosensor Knee Balancer

• • Terminated Z-1029-2015 FDA Class II ·initiated 5 Dec 2014

  Presence of one inoperable (dead) sensor pad.

510(k) Number

K130380 ↗

FDA Product Code

ONN

FDA applicant

Orthosensor, Inc.

Device Class

Class II

Regulation

21 CFR Part 882.4560

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• VERASENSE Knee System

  Class II

  FDA 510(k) K150372 Active Cleared 15 Apr 2016

• VERASENSE for Stryker Triathlon

  Class II

  FDA 510(k) K200665 Active Cleared 12 Apr 2020

• Orthosensor Knee Balancer, Verasense Knee System

  Class II

  FDA 510(k) K131767 Active Cleared 8 Nov 2013

• VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder

  Class II

  FDA 510(k) K200587 Active Cleared 25 Aug 2020

• Orthorex Intra-Operative Load Sensor

  Class II

  FDA 510(k) K090474 Active Cleared 19 Oct 2009

• 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

  Class II

  FDA 510(k) K193580 Active Cleared 1 Apr 2020

See all devices from Orthosensor Inc →