FDA 510(k)

STRYKER REMOTE SURGICAL PLANNING SYSTEM

K-Number: K004027 · 2001-01-24

Decision Date2001-01-24

Product CodeHAW

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

STRYKER REMOTE SURGICAL PLANNING 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 2001-01-24 under 510(k) number K004027. 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 REMOTE SURGICAL PLANNING SYSTEM?

STRYKER REMOTE SURGICAL PLANNING SYSTEM is a medical device that received FDA 510(k) clearance on 2001-01-24. The listed applicant is Stryker Instruments. The 510(k) number is K004027.

When did STRYKER REMOTE SURGICAL PLANNING SYSTEM receive FDA 510(k) clearance?

STRYKER REMOTE SURGICAL PLANNING SYSTEM received FDA 510(k) clearance on 2001-01-24, under 510(k) number K004027.

Who is the listed applicant for STRYKER REMOTE SURGICAL PLANNING 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 REMOTE SURGICAL PLANNING SYSTEM?

The FDA product code for STRYKER REMOTE SURGICAL PLANNING 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.