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FDA 510(k)

SMARTSET MV BONE CEMENT

K-Number: K081155 · 2008-05-14

ApplicantDePuy Orthopaedics, Inc.
Decision Date2008-05-14
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMARTSET MV 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 2008-05-14 under 510(k) number K081155. 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 MV BONE CEMENT?

SMARTSET MV BONE CEMENT is a medical device that received FDA 510(k) clearance on 2008-05-14. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K081155.

When did SMARTSET MV BONE CEMENT receive FDA 510(k) clearance?

SMARTSET MV BONE CEMENT received FDA 510(k) clearance on 2008-05-14, under 510(k) number K081155.

Who is the listed applicant for SMARTSET MV 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 MV BONE CEMENT?

The FDA product code for SMARTSET MV 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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