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FDA 510(k)

UNIVERSAL TOTAL WRIST SYSTEM

K-Number: K030037 · 2003-02-05

ApplicantKinetikos Medical, Inc.
Decision Date2003-02-05
Product CodeJWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL TOTAL WRIST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Kinetikos Medical, Inc.. It received FDA 510(k) clearance on 2003-02-05 under 510(k) number K030037. The device is classified under product code JWJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIVERSAL TOTAL WRIST SYSTEM?

UNIVERSAL TOTAL WRIST SYSTEM is a medical device that received FDA 510(k) clearance on 2003-02-05. The listed applicant is Kinetikos Medical, Inc.. The 510(k) number is K030037.

When did UNIVERSAL TOTAL WRIST SYSTEM receive FDA 510(k) clearance?

UNIVERSAL TOTAL WRIST SYSTEM received FDA 510(k) clearance on 2003-02-05, under 510(k) number K030037.

Who is the listed applicant for UNIVERSAL TOTAL WRIST SYSTEM?

The FDA 510(k) record lists Kinetikos Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNIVERSAL TOTAL WRIST SYSTEM?

The FDA product code for UNIVERSAL TOTAL WRIST SYSTEM is JWJ.

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Other records listing Kinetikos Medical, Inc. as applicant

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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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