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FDA 510(k)

OSTEOPAL plus

K-Number: K153737 · 2016-04-22

ApplicantHeraeus Medical GmbH
Decision Date2016-04-22
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEOPAL plus is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Medical GmbH. It received FDA 510(k) clearance on 2016-04-22 under 510(k) number K153737. 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 plus?

OSTEOPAL plus is a medical device that received FDA 510(k) clearance on 2016-04-22. The listed applicant is Heraeus Medical GmbH. The 510(k) number is K153737.

When did OSTEOPAL plus receive FDA 510(k) clearance?

OSTEOPAL plus received FDA 510(k) clearance on 2016-04-22, under 510(k) number K153737.

Who is the listed applicant for OSTEOPAL plus?

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

What is the FDA product code for OSTEOPAL plus?

The FDA product code for OSTEOPAL plus is LOD.

Other records listing Heraeus Medical GmbH 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.

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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

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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