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FDA 510(k)

TrueLok Elevate

K-Number: K242861 · 2024-12-03

ApplicantOrthofix Srl
Decision Date2024-12-03
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TrueLok Elevate is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix Srl. It received FDA 510(k) clearance on 2024-12-03 under 510(k) number K242861. 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 TrueLok Elevate?

TrueLok Elevate is a medical device that received FDA 510(k) clearance on 2024-12-03. The listed applicant is Orthofix Srl. The 510(k) number is K242861.

When did TrueLok Elevate receive FDA 510(k) clearance?

TrueLok Elevate received FDA 510(k) clearance on 2024-12-03, under 510(k) number K242861.

Who is the listed applicant for TrueLok Elevate?

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

What is the FDA product code for TrueLok Elevate?

The FDA product code for TrueLok Elevate 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.

NCT07079774TrueLok Elevate PMCF StudyRECRUITING

Other records listing Orthofix Srl 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.

K260146FITBONE® TRANSPORT AND LENGTHENING SYSTEMK253991Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAK250112FitboneTM TrochantericK242270OrthoNext Platform SystemK233867Fitbone TrochantericK232648RODEO Telescopic Nail

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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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