FDA 510(k)

STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000

K-Number: K062640 · 2006-12-14

Decision Date2006-12-14

Product CodeHAW

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000 is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Instruments. It received FDA 510(k) clearance on 2006-12-14 under 510(k) number K062640. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000?

STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000 is a medical device that received FDA 510(k) clearance on 2006-12-14. The listed applicant is Stryker Instruments. The 510(k) number is K062640.

When did STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000 receive FDA 510(k) clearance?

STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000 received FDA 510(k) clearance on 2006-12-14, under 510(k) number K062640.

Who is the listed applicant for STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000?

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 NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000?

The FDA product code for STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000 is HAW.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.