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FDA 510(k)

LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS

K-Number: K081244 · 2008-07-30

ApplicantBiomet Trauma
Decision Date2008-07-30
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Trauma. It received FDA 510(k) clearance on 2008-07-30 under 510(k) number K081244. 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 LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS?

LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS is a medical device that received FDA 510(k) clearance on 2008-07-30. The listed applicant is Biomet Trauma. The 510(k) number is K081244.

When did LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS receive FDA 510(k) clearance?

LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS received FDA 510(k) clearance on 2008-07-30, under 510(k) number K081244.

Who is the listed applicant for LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS?

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

What is the FDA product code for LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS?

The FDA product code for LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS is KTT.

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Other records listing Biomet Trauma as applicant

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.

K091976BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAILK092078OPTILOCK PERIARTICULAR PLATINGK082874BIODRIVE CANNULATED SCREW SYSTEMK081243BIOMET PHOENIX ANKLE NAIL SYSTEMK071325BIOMET VARIABLE LOCKING PLATE SYSTEMK070823GROWTH CONTROL PLATING SYSTEM

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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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