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FDA 510(k)

OXFORD EXTERNAL FIXATION SYSTEM

K-Number: K800184 · 1980-02-11

ApplicantDowns Surgical , Ltd.
Decision Date1980-02-11
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OXFORD EXTERNAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Downs Surgical , Ltd.. It received FDA 510(k) clearance on 1980-02-11 under 510(k) number K800184. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXFORD EXTERNAL FIXATION SYSTEM?

OXFORD EXTERNAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 1980-02-11. The listed applicant is Downs Surgical , Ltd.. The 510(k) number is K800184.

When did OXFORD EXTERNAL FIXATION SYSTEM receive FDA 510(k) clearance?

OXFORD EXTERNAL FIXATION SYSTEM received FDA 510(k) clearance on 1980-02-11, under 510(k) number K800184.

Who is the listed applicant for OXFORD EXTERNAL FIXATION SYSTEM?

The FDA 510(k) record lists Downs Surgical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OXFORD EXTERNAL FIXATION SYSTEM?

The FDA product code for OXFORD EXTERNAL FIXATION SYSTEM is JEC.

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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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