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FDA 510(k)

OSTEOPAL® V

K-Number: K241674 · 2024-12-05

ApplicantHeraeus Medical GmbH
Decision Date2024-12-05
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEOPAL® V 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 2024-12-05 under 510(k) number K241674. 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® V?

OSTEOPAL® V is a medical device that received FDA 510(k) clearance on 2024-12-05. The listed applicant is Heraeus Medical GmbH. The 510(k) number is K241674.

When did OSTEOPAL® V receive FDA 510(k) clearance?

OSTEOPAL® V received FDA 510(k) clearance on 2024-12-05, under 510(k) number K241674.

Who is the listed applicant for OSTEOPAL® V?

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® V?

The FDA product code for OSTEOPAL® V is LOD.

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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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