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FDA PRODUCT CODE · CLASS II

QUW — Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament

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

DEVICE CLASS
Class II
REGULATION
21 CFR 878.3300
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
OR
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
3
510(K)/PMA CLEARANCES
510k: 3
0
RECALL ENTRIES

Recent clearances

K261621Theramicro · 510k2026-06-09
K242237Xiros Limited · 510k2025-07-15
K251063Theramicro · 510k2025-05-30

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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