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FDA 510(k)

SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT

K-Number: K053445 · 2006-01-06

ApplicantDePuy Orthopaedics, Inc.
Decision Date2006-01-06
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV 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 2006-01-06 under 510(k) number K053445. 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 SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT?

SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT is a medical device that received FDA 510(k) clearance on 2006-01-06. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K053445.

When did SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT receive FDA 510(k) clearance?

SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT received FDA 510(k) clearance on 2006-01-06, under 510(k) number K053445.

Who is the listed applicant for SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV 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 SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT?

The FDA product code for SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT is LOD.

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Related Devices (Code: LOD)

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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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