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FDA 510(k)

STRYKER NAVIGATION SYSTEM-SPINE & FLUOROSCOPY MODULES

K-Number: K003111 · 2001-01-04

ApplicantStryker Instruments
Decision Date2001-01-04
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STRYKER NAVIGATION SYSTEM-SPINE & FLUOROSCOPY MODULES is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Instruments. It received FDA 510(k) clearance on 2001-01-04 under 510(k) number K003111. 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-SPINE & FLUOROSCOPY MODULES?

STRYKER NAVIGATION SYSTEM-SPINE & FLUOROSCOPY MODULES is a medical device that received FDA 510(k) clearance on 2001-01-04. The listed applicant is Stryker Instruments. The 510(k) number is K003111.

When did STRYKER NAVIGATION SYSTEM-SPINE & FLUOROSCOPY MODULES receive FDA 510(k) clearance?

STRYKER NAVIGATION SYSTEM-SPINE & FLUOROSCOPY MODULES received FDA 510(k) clearance on 2001-01-04, under 510(k) number K003111.

Who is the listed applicant for STRYKER NAVIGATION SYSTEM-SPINE & FLUOROSCOPY MODULES?

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-SPINE & FLUOROSCOPY MODULES?

The FDA product code for STRYKER NAVIGATION SYSTEM-SPINE & FLUOROSCOPY MODULES is HAW.

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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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