FDA 510(k)

OSTEOPAL plus

K-Number: K153737 · 2016-04-22

Decision Date2016-04-22

Product CodeLOD

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

OSTEOPAL plus is a medical device manufactured by Heraeus Medical GmbH. It received FDA 510(k) clearance on 2016-04-22 under approval 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. It is manufactured by Heraeus Medical GmbH. The 510(k) number is K153737.

When was OSTEOPAL plus approved by the FDA?

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

What company makes OSTEOPAL plus?

OSTEOPAL plus is manufactured by Heraeus Medical GmbH.

What is the FDA product code for OSTEOPAL plus?

The FDA product code for OSTEOPAL plus 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.