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FDA 510(k)

STRYKER SPINE OASYS SYSTEM

K-Number: K032394 · 2004-02-20

ApplicantHowmedica Osteonics Corp.
Decision Date2004-02-20
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STRYKER SPINE OASYS SYSTEM 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 2004-02-20 under 510(k) number K032394. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRYKER SPINE OASYS SYSTEM?

STRYKER SPINE OASYS SYSTEM is a medical device that received FDA 510(k) clearance on 2004-02-20. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K032394.

When did STRYKER SPINE OASYS SYSTEM receive FDA 510(k) clearance?

STRYKER SPINE OASYS SYSTEM received FDA 510(k) clearance on 2004-02-20, under 510(k) number K032394.

Who is the listed applicant for STRYKER SPINE OASYS SYSTEM?

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 STRYKER SPINE OASYS SYSTEM?

The FDA product code for STRYKER SPINE OASYS SYSTEM is MNI.

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Related Devices (Code: MNI)

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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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