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FDA 510(k)

HOFFMANN II COMPACT BALTIMORE COUPLING

K-Number: K031941 · 2003-07-24

ApplicantHowmedica Osteonics Corp.
Decision Date2003-07-24
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HOFFMANN II COMPACT BALTIMORE COUPLING is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp.. It received FDA 510(k) clearance on 2003-07-24 under 510(k) number K031941. 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 HOFFMANN II COMPACT BALTIMORE COUPLING?

HOFFMANN II COMPACT BALTIMORE COUPLING is a medical device that received FDA 510(k) clearance on 2003-07-24. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K031941.

When did HOFFMANN II COMPACT BALTIMORE COUPLING receive FDA 510(k) clearance?

HOFFMANN II COMPACT BALTIMORE COUPLING received FDA 510(k) clearance on 2003-07-24, under 510(k) number K031941.

Who is the listed applicant for HOFFMANN II COMPACT BALTIMORE COUPLING?

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

What is the FDA product code for HOFFMANN II COMPACT BALTIMORE COUPLING?

The FDA product code for HOFFMANN II COMPACT BALTIMORE COUPLING 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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