Bonos R 1X20, Bonos R 2X20, Bonos R 1X40, Bonos R 2X40, Bonos R 1X60

FDA 510(k) K123225 · Aap Biomaterials GmbH & Co. KG

Substantially Equivalent

510(k) numberK123225

Submission

Device name
Bonos R 1X20, Bonos R 2X20, Bonos R 1X40, Bonos R 2X40, Bonos R 1X60
Applicant
Aap Biomaterials GmbH & Co. KG
Dieburg, DE
Received
October 15, 2012
Decision date
March 15, 2013
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LOD – Bone Cement
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3027
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code LOD

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K254107Refobacin Bone Cement R (110034355)LOD · Traditional Biomet France04/15/2026SE
K250760SPECTRUM GV Bone CementLOD · Special Osteoremedies, LLC04/02/2025SE
K241674Osteopal® VLOD · Traditional Heraeus Medical GmbH12/05/2024SE
K231556SPECTRUM® GV Bone CementLOD · Traditional Osteoremedies, LLC12/20/2023SE
K211163Bone Cement Genta, Bone Cement HV, Bone Cement LVLOD · Traditional Tecres S.P.A.01/09/2023SE
K212729Bone Cement-Normal ViscosityLOD · Traditional Biomecanica Industria E Comerciode Produtos…05/31/2022SE
K211869OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA)…LOD · Traditional Ormed Grup Medikal Turizm Saglik Hizmetleri…05/19/2022SE
K213812PALACOS MV proLOD · Traditional Heraeus Medical GmbH02/02/2022SE
K210607PALACOS R pro, PALACOS R+G pro, PALACOS MV+G proLOD · Traditional Heraeus Medical GmbH07/09/2021SE
K202458BonOs Inject, Pedicle screw kits, Cement pusherLOD · Traditional Osartis GmbH05/18/2021SE

More from Osartis GmbH

510(k)DeviceDecision
K123081Bonos R Genta 1X20 Model 01-0228; Bonos R Genta 2X20 Model 01-0229; Bonos R Genta 1X40…LOD · Abbreviated 03/07/2013SE
K121876Vertecem II Cement KitNDN · Abbreviated 10/19/2012SE
K090460Bonos InjectNDN · Abbreviated 04/14/2009SE

Questions and answers

When was Bonos R 1X20, Bonos R 2X20, Bonos R 1X40, Bonos R 2X40, Bonos R 1X60 cleared by the FDA?

Bonos R 1X20, Bonos R 2X20, Bonos R 1X40, Bonos R 2X40, Bonos R 1X60 (K123225) received a 510(k) decision of Substantially Equivalent on March 15, 2013, 151 days after the submission was received.

What is the product code of K123225?

The FDA product code is LOD – Bone Cement, a Class II (moderate risk) device regulated under 21 CFR 888.3027.