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FDA 510(k)

Guided Growth Plate System Plus

K-Number: K180624 · 2018-05-15

ApplicantOrthofix Srl
Decision Date2018-05-15
Product CodeOBT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Guided Growth Plate System Plus is a medical device manufactured by Orthofix Srl. It received FDA 510(k) clearance on 2018-05-15 under approval number K180624. The device is classified under product code OBT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Guided Growth Plate System Plus?

Guided Growth Plate System Plus is a medical device that received FDA 510(k) clearance on 2018-05-15. It is manufactured by Orthofix Srl. The 510(k) number is K180624.

When was Guided Growth Plate System Plus approved by the FDA?

Guided Growth Plate System Plus received FDA 510(k) clearance on 2018-05-15, under approval number K180624.

What company makes Guided Growth Plate System Plus?

Guided Growth Plate System Plus is manufactured by Orthofix Srl.

What is the FDA product code for Guided Growth Plate System Plus?

The FDA product code for Guided Growth Plate System Plus is OBT.

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Related Devices (Code: OBT)

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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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