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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 the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Medical GmbH. It received FDA 510(k) clearance on 2021-07-09 under 510(k) 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. The listed applicant is Heraeus Medical GmbH. The 510(k) number is K210607.

When did PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro receive FDA 510(k) clearance?

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

Who is the listed applicant for PALACOS R pro, PALACOS R+G pro, PALACOS MV+G 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 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 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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