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FDA 510(k)

SIMPLEX P SPEEDSET BONE CEMENT

K-Number: K053198 · 2006-01-26

ApplicantHowmedica Osteonics Corp.
Decision Date2006-01-26
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SIMPLEX P SPEEDSET BONE CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp.. It received FDA 510(k) clearance on 2006-01-26 under 510(k) number K053198. 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 SIMPLEX P SPEEDSET BONE CEMENT?

SIMPLEX P SPEEDSET BONE CEMENT is a medical device that received FDA 510(k) clearance on 2006-01-26. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K053198.

When did SIMPLEX P SPEEDSET BONE CEMENT receive FDA 510(k) clearance?

SIMPLEX P SPEEDSET BONE CEMENT received FDA 510(k) clearance on 2006-01-26, under 510(k) number K053198.

Who is the listed applicant for SIMPLEX P SPEEDSET BONE CEMENT?

The FDA 510(k) record lists Howmedica Osteonics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIMPLEX P SPEEDSET BONE CEMENT?

The FDA product code for SIMPLEX P SPEEDSET 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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