510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QUWClass II

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

21 CFR 878.3300 / General, Plastic Surgery
FDA source (opens on fda.gov)

QUW is the FDA product code for Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament, a class II device type, regulated under 21 CFR 878.3300. FDA's definition for this code reads: "a non-resorbable orthopedic mesh used for reinforcement of soft tissue where weakness exists in ligament repair". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QUW
Device name
Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament
FDA definition
a non-resorbable orthopedic mesh used for reinforcement of soft tissue where weakness exists in ligament repair.
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code QUW

By decision year
5 clearances under product code QUW with a decision year between 2022 and 2026, 2025 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QUW by decision year
YearClearances
20221
20252
20262

Applicants with the most clearances

Product code QUW
Applicants holding the most 510(k) clearances under product code QUW
ApplicantClearances
Theramicro2
Theramicro1
Xiros Limited1
Xiros Ltd1

Companies listing this code with FDA

Companies whose registered establishments list this code