510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K844225Substantially Equivalent

Link Acetabular Mesh

Waldemar Link GmbH & Co. KG, E. Hanover NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844225 is the FDA 510(k) clearance record for LINK ACETABULAR MESH, a class II device, cleared for Waldemar Link GmbH & Co. KG on under FDA product code FTM (Mesh, Surgical). FDA records list 43 510(k) clearances for Waldemar Link GmbH & Co. KG, from to . As of , FDA records show no recalls naming K844225.

Clearance record

Decision date
Received
(13 days to decision)
Product code
FTM Mesh, Surgical
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Waldemar Link GmbH & Co. KG 10 Great Meadow Ln., E. Hanover NJ
Third party review
No

Clearances, product code FTM

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