FDA.reportPublic FDA data

510(k) K222978

Device
Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
Applicant
Xiros, Ltd.
510(k) number
K222978
Product code
QUW
Decision
Substantially Equivalent (SESE)
Decision date
2022-12-27
Date received
2022-09-28
Regulation
878.3300
Classification name
Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Steve Curran
Address
Springfield House Ln., Whitehouse Ln. Leeds GB LS17 7UE LS17 7UE

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QUW#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K242237Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited2025-07-15
K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro2025-05-30