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FDA 510(k)

The GIRO Growth Modulation System

K-Number: K220190 · 2022-10-24

ApplicantPega Medical, Inc.
Decision Date2022-10-24
Product CodeOBT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

The GIRO Growth Modulation System is a medical device manufactured by Pega Medical, Inc.. It received FDA 510(k) clearance on 2022-10-24 under approval number K220190. 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 The GIRO Growth Modulation System?

The GIRO Growth Modulation System is a medical device that received FDA 510(k) clearance on 2022-10-24. It is manufactured by Pega Medical, Inc.. The 510(k) number is K220190.

When was The GIRO Growth Modulation System approved by the FDA?

The GIRO Growth Modulation System received FDA 510(k) clearance on 2022-10-24, under approval number K220190.

What company makes The GIRO Growth Modulation System?

The GIRO Growth Modulation System is manufactured by Pega Medical, Inc..

What is the FDA product code for The GIRO Growth Modulation System?

The FDA product code for The GIRO Growth Modulation System is OBT.

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Related PubMed Literature

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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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