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FDA 510(k)

STRYKER TOTAL PERFORMANCE SYSTEM

K-Number: K943589 · 1994-12-15

ApplicantStryker Corp.
Decision Date1994-12-15
Product CodeHWE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STRYKER TOTAL PERFORMANCE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corp.. It received FDA 510(k) clearance on 1994-12-15 under 510(k) number K943589. The device is classified under product code HWE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRYKER TOTAL PERFORMANCE SYSTEM?

STRYKER TOTAL PERFORMANCE SYSTEM is a medical device that received FDA 510(k) clearance on 1994-12-15. The listed applicant is Stryker Corp.. The 510(k) number is K943589.

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

STRYKER TOTAL PERFORMANCE SYSTEM received FDA 510(k) clearance on 1994-12-15, under 510(k) number K943589.

Who is the listed applicant for STRYKER TOTAL PERFORMANCE SYSTEM?

The FDA 510(k) record lists Stryker Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STRYKER TOTAL PERFORMANCE SYSTEM?

The FDA product code for STRYKER TOTAL PERFORMANCE SYSTEM is HWE.

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Other records listing Stryker Corp. as applicant

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Related Devices (Code: HWE)

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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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