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FDA 510(k)

INCUDOSTAPEDIAL JOINT

K-Number: K925443 · 1993-03-08

ApplicantSmith & Nephew Richards, Inc.
Decision Date1993-03-08
Product CodeETB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

INCUDOSTAPEDIAL JOINT is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Richards, Inc.. It received FDA 510(k) clearance on 1993-03-08 under 510(k) number K925443. The device is classified under product code ETB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INCUDOSTAPEDIAL JOINT?

INCUDOSTAPEDIAL JOINT is a medical device that received FDA 510(k) clearance on 1993-03-08. The listed applicant is Smith & Nephew Richards, Inc.. The 510(k) number is K925443.

When did INCUDOSTAPEDIAL JOINT receive FDA 510(k) clearance?

INCUDOSTAPEDIAL JOINT received FDA 510(k) clearance on 1993-03-08, under 510(k) number K925443.

Who is the listed applicant for INCUDOSTAPEDIAL JOINT?

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

What is the FDA product code for INCUDOSTAPEDIAL JOINT?

The FDA product code for INCUDOSTAPEDIAL JOINT is ETB.

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Other records listing Smith & Nephew Richards, Inc. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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