FDA.report

510(k) K242237

Device
Jewel Soft Tissue Reinforcement Device (102-6005)
Applicant
Xiros Limited
510(k) number
K242237
Product code
QUW
Decision
Substantially Equivalent (SESE)
Decision date
2025-07-15
Date received
2024-07-30
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
N

Related Records

Applicant Contact

Contact
Grannells Janet
Address
Springfield House Whitehouse Ln. Yeadon GB LS19 7UE LS19 7UE

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code QUW

510(k)DeviceApplicantDecision date
K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro2025-05-30
K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.2022-12-27