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FDA 510(k)

BONE SOURCE HAC RAPID SETTING CEMENT

K-Number: K043334 · 2005-02-09

ApplicantStryker Instruments
Decision Date2005-02-09
Product CodeGXP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BONE SOURCE HAC RAPID SETTING CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Instruments. It received FDA 510(k) clearance on 2005-02-09 under 510(k) number K043334. The device is classified under product code GXP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONE SOURCE HAC RAPID SETTING CEMENT?

BONE SOURCE HAC RAPID SETTING CEMENT is a medical device that received FDA 510(k) clearance on 2005-02-09. The listed applicant is Stryker Instruments. The 510(k) number is K043334.

When did BONE SOURCE HAC RAPID SETTING CEMENT receive FDA 510(k) clearance?

BONE SOURCE HAC RAPID SETTING CEMENT received FDA 510(k) clearance on 2005-02-09, under 510(k) number K043334.

Who is the listed applicant for BONE SOURCE HAC RAPID SETTING CEMENT?

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

What is the FDA product code for BONE SOURCE HAC RAPID SETTING CEMENT?

The FDA product code for BONE SOURCE HAC RAPID SETTING CEMENT is GXP.

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Related Devices (Code: GXP)

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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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