Palamed Bone Cement

FDA 510(k) K010586 · Merck Biomaterial GmbH

Substantially Equivalent

510(k) numberK010586

Submission

Device name
Palamed Bone Cement
Applicant
Merck Biomaterial GmbH
Darmstadt, DE
Received
February 27, 2001
Decision date
October 30, 2001
Decision
Substantially Equivalent (SESE)
Type
Traditional 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

510(k)DeviceApplicantDecision
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

Questions and answers

When was Palamed Bone Cement cleared by the FDA?

Palamed Bone Cement (K010586) received a 510(k) decision of Substantially Equivalent on October 30, 2001, 245 days after the submission was received.

What is the product code of K010586?

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