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FDA 510(k)

PALACOS MV pro

K-Number: K213812 · 2022-02-02

ApplicantHeraeus Medical GmbH
Decision Date2022-02-02
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PALACOS MV pro 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 2022-02-02 under 510(k) number K213812. 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 PALACOS MV pro?

PALACOS MV pro is a medical device that received FDA 510(k) clearance on 2022-02-02. The listed applicant is Heraeus Medical GmbH. The 510(k) number is K213812.

When did PALACOS MV pro receive FDA 510(k) clearance?

PALACOS MV pro received FDA 510(k) clearance on 2022-02-02, under 510(k) number K213812.

Who is the listed applicant for PALACOS MV pro?

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 PALACOS MV pro?

The FDA product code for PALACOS MV pro 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.

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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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