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FDA 510(k)

PALAMED BONE CEMENT

K-Number: K010586 · 2001-10-30

ApplicantMerck Biomaterial GmbH
Decision Date2001-10-30
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PALAMED BONE CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Merck Biomaterial GmbH. It received FDA 510(k) clearance on 2001-10-30 under 510(k) number K010586. The device is classified under product code LOD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PALAMED BONE CEMENT?

PALAMED BONE CEMENT is a medical device that received FDA 510(k) clearance on 2001-10-30. The listed applicant is Merck Biomaterial GmbH. The 510(k) number is K010586.

When did PALAMED BONE CEMENT receive FDA 510(k) clearance?

PALAMED BONE CEMENT received FDA 510(k) clearance on 2001-10-30, under 510(k) number K010586.

Who is the listed applicant for PALAMED BONE CEMENT?

The FDA 510(k) record lists Merck Biomaterial GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PALAMED BONE CEMENT?

The FDA product code for PALAMED BONE CEMENT is LOD.

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Related Devices (Code: LOD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254107Refobacin Bone Cement R (110034355)Biomet FranceK250760SPECTRUM GV Bone CementOsteoremedies, LLCK241674OSTEOPAL® VHeraeus Medical GmbHK231556SPECTRUM® GV Bone CementOsteoremedies, LLCK211163Bone Cement Genta, Bone Cement HV, Bone Cement LVTecres S.P.A.K212729Bone Cement-Normal ViscosityBiomecanica Industria E Comerciode Produtos Ortopedicos Ltda

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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