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FDA 510(k)

HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST

K-Number: K003848 · 2001-01-11

ApplicantHowmedica Osteonics Corp.
Decision Date2001-01-11
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST 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 2001-01-11 under 510(k) number K003848. 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 EXTERNAL FIXATION SYSTEM 90 DEGREE POST?

HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST is a medical device that received FDA 510(k) clearance on 2001-01-11. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K003848.

When did HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST receive FDA 510(k) clearance?

HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST received FDA 510(k) clearance on 2001-01-11, under 510(k) number K003848.

Who is the listed applicant for HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST?

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 EXTERNAL FIXATION SYSTEM 90 DEGREE POST?

The FDA product code for HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST is JEC.

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Related Devices (Code: 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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