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FDA 510(k)

Orthofix TrueLok Hexapod System (TL-HEX) V2.0

K-Number: K170650 · 2017-05-10

ApplicantOrthofix Srl
Decision Date2017-05-10
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Orthofix TrueLok Hexapod System (TL-HEX) V2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix Srl. It received FDA 510(k) clearance on 2017-05-10 under 510(k) number K170650. 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 Orthofix TrueLok Hexapod System (TL-HEX) V2.0?

Orthofix TrueLok Hexapod System (TL-HEX) V2.0 is a medical device that received FDA 510(k) clearance on 2017-05-10. The listed applicant is Orthofix Srl. The 510(k) number is K170650.

When did Orthofix TrueLok Hexapod System (TL-HEX) V2.0 receive FDA 510(k) clearance?

Orthofix TrueLok Hexapod System (TL-HEX) V2.0 received FDA 510(k) clearance on 2017-05-10, under 510(k) number K170650.

Who is the listed applicant for Orthofix TrueLok Hexapod System (TL-HEX) V2.0?

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 Orthofix TrueLok Hexapod System (TL-HEX) V2.0?

The FDA product code for Orthofix TrueLok Hexapod System (TL-HEX) V2.0 is KTT.

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 SystemK242861TrueLok ElevateK233867Fitbone Trochanteric

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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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