510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192394Substantially Equivalent

Hi-Fatigue Bone Cement

Osartis GmbH, Dieburg, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192394 is the FDA 510(k) clearance record for Hi-Fatigue Bone Cement, a class II device, cleared for Osartis GmbH on under FDA product code LOD (Bone Cement). FDA records list 6 510(k) clearances for Osartis GmbH, from to . As of , FDA records show no recalls naming K192394.

Clearance record

Decision date
Received
(90 days to decision)
Product code
LOD Bone Cement
Regulation
21 CFR 888.3027
Device class
Class II
Review panel
Orthopedic
Applicant
Osartis GmbH Lagerstrasse 11-15, Dieburg, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LOD

Trailing 12 months
1 clearance under product code LOD 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 LOD, 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