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FDA 510(k)

STRYKER TOTAL PERFORMANCE (TPS) SYSTEM

K-Number: K032117 · 2003-08-08

ApplicantStryker Instruments
Decision Date2003-08-08
Product CodeDZI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STRYKER TOTAL PERFORMANCE (TPS) 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 2003-08-08 under 510(k) number K032117. The device is classified under product code DZI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRYKER TOTAL PERFORMANCE (TPS) SYSTEM?

STRYKER TOTAL PERFORMANCE (TPS) SYSTEM is a medical device that received FDA 510(k) clearance on 2003-08-08. The listed applicant is Stryker Instruments. The 510(k) number is K032117.

When did STRYKER TOTAL PERFORMANCE (TPS) SYSTEM receive FDA 510(k) clearance?

STRYKER TOTAL PERFORMANCE (TPS) SYSTEM received FDA 510(k) clearance on 2003-08-08, under 510(k) number K032117.

Who is the listed applicant for STRYKER TOTAL PERFORMANCE (TPS) 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 TOTAL PERFORMANCE (TPS) SYSTEM?

The FDA product code for STRYKER TOTAL PERFORMANCE (TPS) SYSTEM is DZI.

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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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