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FDA 510(k)

STEREOTACTIC FRAME BASED SYSTEM

K-Number: K003486 · 2001-05-17

ApplicantStryker Instruments
Decision Date2001-05-17
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STEREOTACTIC FRAME BASED 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 2001-05-17 under 510(k) number K003486. 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 STEREOTACTIC FRAME BASED SYSTEM?

STEREOTACTIC FRAME BASED SYSTEM is a medical device that received FDA 510(k) clearance on 2001-05-17. The listed applicant is Stryker Instruments. The 510(k) number is K003486.

When did STEREOTACTIC FRAME BASED SYSTEM receive FDA 510(k) clearance?

STEREOTACTIC FRAME BASED SYSTEM received FDA 510(k) clearance on 2001-05-17, under 510(k) number K003486.

Who is the listed applicant for STEREOTACTIC FRAME BASED 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 STEREOTACTIC FRAME BASED SYSTEM?

The FDA product code for STEREOTACTIC FRAME BASED SYSTEM 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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