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FDA 510(k)

SIMPLEX P BONE CEMENT

K-Number: K062553 · 2007-01-08

ApplicantStryker Orthopaedics
Decision Date2007-01-08
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SIMPLEX P BONE CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Orthopaedics. It received FDA 510(k) clearance on 2007-01-08 under 510(k) number K062553. 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 BONE CEMENT?

SIMPLEX P BONE CEMENT is a medical device that received FDA 510(k) clearance on 2007-01-08. The listed applicant is Stryker Orthopaedics. The 510(k) number is K062553.

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

SIMPLEX P BONE CEMENT received FDA 510(k) clearance on 2007-01-08, under 510(k) number K062553.

Who is the listed applicant for SIMPLEX P BONE CEMENT?

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

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

The FDA product code for SIMPLEX P BONE CEMENT is 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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