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FDA 510(k)

OSTEOPAL

K-Number: K030903 · 2003-09-23

ApplicantHeraeus Kulzer GmbH & Co. KG
Decision Date2003-09-23
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEOPAL 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 2003-09-23 under 510(k) number K030903. 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 OSTEOPAL?

OSTEOPAL is a medical device that received FDA 510(k) clearance on 2003-09-23. The listed applicant is Heraeus Kulzer GmbH & Co. KG. The 510(k) number is K030903.

When did OSTEOPAL receive FDA 510(k) clearance?

OSTEOPAL received FDA 510(k) clearance on 2003-09-23, under 510(k) number K030903.

Who is the listed applicant for OSTEOPAL?

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 OSTEOPAL?

The FDA product code for OSTEOPAL 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.

K031673REFOBACIN -PALACOS GK030902PALACOS RK022251PALABOND

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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