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FDA 510(k)

PALABOND

K-Number: K022251 · 2003-02-26

ApplicantHeraeus Kulzer GmbH & Co. KG
Decision Date2003-02-26
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PALABOND 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 2003-02-26 under 510(k) number K022251. 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 PALABOND?

PALABOND is a medical device that received FDA 510(k) clearance on 2003-02-26. The listed applicant is Heraeus Kulzer GmbH & Co. KG. The 510(k) number is K022251.

When did PALABOND receive FDA 510(k) clearance?

PALABOND received FDA 510(k) clearance on 2003-02-26, under 510(k) number K022251.

Who is the listed applicant for PALABOND?

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 PALABOND?

The FDA product code for PALABOND is LOD.

Related Clinical Trials

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.

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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.

K031673REFOBACIN -PALACOS GK030902PALACOS RK030903OSTEOPAL

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

View on FDA Database →

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

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