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

Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament

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

QWJ is the FDA product code for Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament, a class II device type, regulated under 21 CFR 878.3300. FDA's definition for this code reads: "For reinforcement of soft tissue where weakness exists in ligament repair". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QWJ
Device name
Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament
FDA definition
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
1
Ingested recalls
0

Clearances, product code QWJ

By decision year
1 clearance under product code QWJ with a decision year between 2026 and 2026, 2026 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QWJ by decision year
YearClearances
20261

Applicants with the most clearances

Product code QWJ
Applicants holding the most 510(k) clearances under product code QWJ
ApplicantClearances
International Life Sciences1

Companies listing this code with FDA

Companies whose registered establishments list this code