FDA.reportPublic FDA data

510(k) K251063

Device
TekBrace Solo Soft Tissue Reinforcement Device
Applicant
Theramicro
510(k) number
K251063
Product code
QUW
Decision
Substantially Equivalent (SESE)
Decision date
2025-05-30
Date received
2025-04-04
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
Christine Scifert
Address
51 Germantown Ct. Suite 200 Cordova TN US 38018 38018

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
K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.2022-12-27