FDA.report

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
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Christine Scifert
Address
51 Germantown Ct. Suite 200 Cordova TN US 38018 38018

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
00810198920062TekBrace SoloTheraMicro, LLC2025-08-29
00810198920055TekBrace SoloTheraMicro, LLC2025-08-29

Other 510(k) Records For Product Code QUW

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