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FDA 510(k)

HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM

K-Number: K042019 · 2004-09-24

ApplicantHowmedica Osteonics Corp.
Decision Date2004-09-24
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM 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 2004-09-24 under 510(k) number K042019. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM?

HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2004-09-24. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K042019.

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

HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM received FDA 510(k) clearance on 2004-09-24, under 510(k) number K042019.

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

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 MICRO EXTERNAL FIXATION SYSTEM?

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

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Related Devices (Code: KTT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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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