FDA.reportPublic FDA data

510(k) K241298

Device
QUADSENSE
Applicant
Eventum Orthopaedics, Ltd.
510(k) number
K241298
Product code
ONN
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-04
Date received
2024-05-08
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
John Naybour
Address
Richmond House, Lawnswood Business Park Redvers Close Leeds GB LS16 6QY LS16 6QY

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ONN#

510(k), Device, Applicant table
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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