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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 a medical device manufactured by Orthofix Srl. It received FDA 510(k) clearance on 2017-05-10 under approval 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. It is manufactured by Orthofix Srl. The 510(k) number is K170650.

When was Orthofix TrueLok Hexapod System (TL-HEX) V2.0 approved by the FDA?

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

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

Orthofix TrueLok Hexapod System (TL-HEX) V2.0 is manufactured by Orthofix Srl.

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.

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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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