510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K123081Substantially Equivalent

Bonos R Genta 1X20 Model 01-0228; Bonos R Genta 2X20 Model 01-0229; Bonos R Genta 1X40 Model 01-0217; Bonos R Genta 2X40

Aap Biomaterials GmbH & Co. KG, Dieburg, DE / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123081 is the FDA 510(k) clearance record for BONOS R GENTA 1X20 MODEL 01-0228; BONOS R GENTA 2X20 MODEL 01-0229; BONOS R GENTA 1X40 MODEL 01-0217; BONOS R GENTA 2X40, a class II device, cleared for Aap Biomaterials GmbH & Co. KG on under FDA product code LOD (Bone Cement). FDA records list 2 510(k) clearances for Aap Biomaterials GmbH & Co. KG, from to . As of , FDA records show one recall naming K123081.

Clearance record

Decision date
Received
(157 days to decision)
Product code
LOD Bone Cement
Regulation
21 CFR 888.3027
Device class
Class II
Review panel
Orthopedic
Applicant
Aap Biomaterials GmbH & Co. KG 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