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FDA 510(k)

SMALL JOINT SYSTEM

K-Number: K914559 · 1992-02-18

ApplicantSmith & Nephew Dyonics, Inc.
Decision Date1992-02-18
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMALL JOINT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Dyonics, Inc.. It received FDA 510(k) clearance on 1992-02-18 under 510(k) number K914559. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMALL JOINT SYSTEM?

SMALL JOINT SYSTEM is a medical device that received FDA 510(k) clearance on 1992-02-18. The listed applicant is Smith & Nephew Dyonics, Inc.. The 510(k) number is K914559.

When did SMALL JOINT SYSTEM receive FDA 510(k) clearance?

SMALL JOINT SYSTEM received FDA 510(k) clearance on 1992-02-18, under 510(k) number K914559.

Who is the listed applicant for SMALL JOINT SYSTEM?

The FDA 510(k) record lists Smith & Nephew Dyonics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMALL JOINT SYSTEM?

The FDA product code for SMALL JOINT SYSTEM is HRX.

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Other records listing Smith & Nephew Dyonics, 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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