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FDA 510(k)

SOUTER STRATHCLYDE TOTAL ELBOW SYSTEM

K-Number: K880188 · 1988-03-01

ApplicantHowmedica Corp.
Decision Date1988-03-01
Product CodeJDB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SOUTER STRATHCLYDE TOTAL ELBOW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1988-03-01 under 510(k) number K880188. The device is classified under product code JDB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOUTER STRATHCLYDE TOTAL ELBOW SYSTEM?

SOUTER STRATHCLYDE TOTAL ELBOW SYSTEM is a medical device that received FDA 510(k) clearance on 1988-03-01. The listed applicant is Howmedica Corp.. The 510(k) number is K880188.

When did SOUTER STRATHCLYDE TOTAL ELBOW SYSTEM receive FDA 510(k) clearance?

SOUTER STRATHCLYDE TOTAL ELBOW SYSTEM received FDA 510(k) clearance on 1988-03-01, under 510(k) number K880188.

Who is the listed applicant for SOUTER STRATHCLYDE TOTAL ELBOW SYSTEM?

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

What is the FDA product code for SOUTER STRATHCLYDE TOTAL ELBOW SYSTEM?

The FDA product code for SOUTER STRATHCLYDE TOTAL ELBOW SYSTEM is JDB.

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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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