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FDA 510(k)

SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT

K-Number: K033382 · 2004-02-05

ApplicantDePuy Orthopaedics, Inc.
Decision Date2004-02-05
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2004-02-05 under 510(k) number K033382. 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 SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT?

SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT is a medical device that received FDA 510(k) clearance on 2004-02-05. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K033382.

When did SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT receive FDA 510(k) clearance?

SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT received FDA 510(k) clearance on 2004-02-05, under 510(k) number K033382.

Who is the listed applicant for SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT?

The FDA 510(k) record lists DePuy Orthopaedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT?

The FDA product code for SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT is LOD.

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Other records listing DePuy Orthopaedics, Inc. as applicant

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Related Devices (Code: LOD)

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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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