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FDA 510(k)

REFOBACIN -PALACOS G

K-Number: K031673 · 2004-05-25

ApplicantHeraeus Kulzer GmbH & Co. KG
Decision Date2004-05-25
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REFOBACIN -PALACOS G is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer GmbH & Co. KG. It received FDA 510(k) clearance on 2004-05-25 under 510(k) number K031673. 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 REFOBACIN -PALACOS G?

REFOBACIN -PALACOS G is a medical device that received FDA 510(k) clearance on 2004-05-25. The listed applicant is Heraeus Kulzer GmbH & Co. KG. The 510(k) number is K031673.

When did REFOBACIN -PALACOS G receive FDA 510(k) clearance?

REFOBACIN -PALACOS G received FDA 510(k) clearance on 2004-05-25, under 510(k) number K031673.

Who is the listed applicant for REFOBACIN -PALACOS G?

The FDA 510(k) record lists Heraeus Kulzer GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REFOBACIN -PALACOS G?

The FDA product code for REFOBACIN -PALACOS G is LOD.

Related Clinical Trials

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Other records listing Heraeus Kulzer GmbH & Co. KG as applicant

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.

K030902PALACOS RK030903OSTEOPALK022251PALABOND

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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