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FDA 510(k)

PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro

K-Number: K210607 · 2021-07-09

ApplicantHeraeus Medical GmbH
Decision Date2021-07-09
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro is a medical device manufactured by Heraeus Medical GmbH. It received FDA 510(k) clearance on 2021-07-09 under approval number K210607. 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 R pro, PALACOS R+G pro, PALACOS MV+G pro?

PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro is a medical device that received FDA 510(k) clearance on 2021-07-09. It is manufactured by Heraeus Medical GmbH. The 510(k) number is K210607.

When was PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro approved by the FDA?

PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro received FDA 510(k) clearance on 2021-07-09, under approval number K210607.

What company makes PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro?

PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro is manufactured by Heraeus Medical GmbH.

What is the FDA product code for PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro?

The FDA product code for PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro is LOD.

Other Devices by Heraeus Medical GmbH

K153737OSTEOPAL plus K182260PALACOS MV K191016COPAL exchange G Hip and Knee Spacers K190766PALACOS fast R+G K202475PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G K220492COPAL exchange G hip spacer

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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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