DeviceClearance

Product code QUW— General, Plastic Surgery

TekBrace Solo Soft Tissue Reinforcement Device

Classification name
Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament
Device class
Class 2
Regulation
21 CFR 878.3300
Advisory panel
General, Plastic Surgery
Total cleared
5
First cleared
Most recent

FDA classification definition

“a non-resorbable orthopedic mesh used for reinforcement of soft tissue where weakness exists in ligament repair.”

— U.S. Food and Drug Administration, device classification record for product code QUW under 21 CFR 878.3300, via openFDA

Market context for product code QUW

FDA has cleared 5 devices under product code QUW between 2022 and 2026, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QUW

Recent clearances under product code QUW

Data sourced from openFDA. This site is unofficial and independent of the FDA.