FDA.reportPublic FDA data

510(k) K200587

Device
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
Applicant
Orthosensor, Inc.
510(k) number
K200587
Product code
ONN
Decision
Substantially Equivalent (SESE)
Decision date
2020-08-25
Date received
2020-03-06
Regulation
882.4560
Classification name
Intraoperative Orthopedic Joint Assessment Aid
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Deborah Escobar Johnson
Address
1855 Griffin Rd. Suite A-310 Dania Beach FL US 33004 33004

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ONN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252524Quadsense (Quadsense and Quadsense Pro)Eventum Orthopaedics, Ltd.2025-09-09
K241298QUADSENSEEventum Orthopaedics, Ltd.2024-10-04
K242616Lantern® HipOrthalign, Inc.2024-10-03
K220830TrueBalance™ Surgical SystemThese Three Medical, LLC2022-09-15
K200665VERASENSE for Stryker TriathlonOrthosensor, Inc.2020-04-12
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.2020-04-01
K180459VERASENSE for Zimmer Biomet PersonaOrthosensor, Inc.2018-06-07
K162237XO1 Knee Balancing SystemXpandortho, Inc.2017-04-25
K150372VERASENSE Knee SystemOrthosensor, Inc.2016-04-15
K132104ELIBRA SOFT-TISSUE FORCE SENSORKamm & Associates2014-03-21
K131767ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEMOrthosensor, Inc.2013-11-08
K130380ORTHOSENSOR KNEE BALANCEROrthosensor, Inc.2013-06-13
K093046ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZESSynvasive Technology, Inc.2011-03-22
K090474ORTHOREX INTRA-OPERATIVE LOAD SENSOROrthosensor, Inc.2009-10-19
K070108ELIBRA DYNAMIC KNEE BALANCERSynvasive Technology, Inc.2007-04-04