FDA 510(k)

STRYKER LEIBINGER CRANIAL FIXATION SYSTEM

K-Number: K030378 · 2003-03-20

Decision Date2003-03-20

Product CodeGXN

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

STRYKER LEIBINGER CRANIAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Instruments. It received FDA 510(k) clearance on 2003-03-20 under 510(k) number K030378. The device is classified under product code GXN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRYKER LEIBINGER CRANIAL FIXATION SYSTEM?

STRYKER LEIBINGER CRANIAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2003-03-20. The listed applicant is Stryker Instruments. The 510(k) number is K030378.

When did STRYKER LEIBINGER CRANIAL FIXATION SYSTEM receive FDA 510(k) clearance?

STRYKER LEIBINGER CRANIAL FIXATION SYSTEM received FDA 510(k) clearance on 2003-03-20, under 510(k) number K030378.

Who is the listed applicant for STRYKER LEIBINGER CRANIAL FIXATION SYSTEM?

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 STRYKER LEIBINGER CRANIAL FIXATION SYSTEM?

The FDA product code for STRYKER LEIBINGER CRANIAL FIXATION SYSTEM is GXN.

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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.