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FDA 510(k)

HOFFMANN II EXTERNAL FIXATION SYSTEM

K-Number: K952730 · 1995-09-08

ApplicantHowmedica Corp.
Decision Date1995-09-08
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HOFFMANN II EXTERNAL FIXATION 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 1995-09-08 under 510(k) number K952730. 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?

HOFFMANN II EXTERNAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 1995-09-08. The listed applicant is Howmedica Corp.. The 510(k) number is K952730.

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

HOFFMANN II EXTERNAL FIXATION SYSTEM received FDA 510(k) clearance on 1995-09-08, under 510(k) number K952730.

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

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

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Other records listing Howmedica Corp. as applicant

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K983528MICRO DYNAMIC MESHK983404TYPE 3 FEMORAL COMPONENTSK980926DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATIONK980925DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATIONK980626DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATIONK980632DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION

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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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