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FDA 510(k)

CONSTRUX EXTERNAL FIXATION DEVICE

K-Number: K111376 · 2011-08-03

ApplicantEbi, LLC
Decision Date2011-08-03
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONSTRUX EXTERNAL FIXATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Ebi, LLC. It received FDA 510(k) clearance on 2011-08-03 under 510(k) number K111376. 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 CONSTRUX EXTERNAL FIXATION DEVICE?

CONSTRUX EXTERNAL FIXATION DEVICE is a medical device that received FDA 510(k) clearance on 2011-08-03. The listed applicant is Ebi, LLC. The 510(k) number is K111376.

When did CONSTRUX EXTERNAL FIXATION DEVICE receive FDA 510(k) clearance?

CONSTRUX EXTERNAL FIXATION DEVICE received FDA 510(k) clearance on 2011-08-03, under 510(k) number K111376.

Who is the listed applicant for CONSTRUX EXTERNAL FIXATION DEVICE?

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

What is the FDA product code for CONSTRUX EXTERNAL FIXATION DEVICE?

The FDA product code for CONSTRUX EXTERNAL FIXATION DEVICE is KTT.

Related Clinical Trials

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.

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Other records listing Ebi, LLC 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.

K113796SOLITAIRE-C CERVICAL SPACER SYSTEM

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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