Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PALACOS MV

K-Number: K182260 · 2018-09-17

ApplicantHeraeus Medical GmbH
Decision Date2018-09-17
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PALACOS MV 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 2018-09-17 under 510(k) number K182260. 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?

PALACOS MV is a medical device that received FDA 510(k) clearance on 2018-09-17. The listed applicant is Heraeus Medical GmbH. The 510(k) number is K182260.

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

PALACOS MV received FDA 510(k) clearance on 2018-09-17, under 510(k) number K182260.

Who is the listed applicant for PALACOS MV?

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?

The FDA product code for PALACOS MV 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.

K241674OSTEOPAL® VK234028COPAL® exchange G hip spacer; COPAL® G+VK222570COPAL knee mouldsK220492COPAL exchange G hip spacerK213812PALACOS MV proK210607PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro

View all 11 devices →

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.

↑