510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K260317Substantially Equivalent

Artelon Convenience Kits

International Life Sciences, Sandy Springs GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K260317 is the FDA 510(k) clearance record for Artelon Convenience Kits, a class II device, cleared for International Life Sciences on under FDA product code QWJ (Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament). FDA's definition for product code QWJ reads: "For reinforcement of soft tissue where weakness exists in ligament repair". FDA records list 4 510(k) clearances for International Life Sciences, from to . As of , FDA records show no recalls naming K260317.

Clearance record

Decision date
Received
(69 days to decision)
Product code
QWJ Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
International Life Sciences 8601 Dunwoody Pl. #250, Sandy Springs GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QWJ

Trailing 12 months
1 clearance under product code QWJ in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QWJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260