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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 the device name listed in this FDA 510(k) record. The listed applicant is Pega Medical, Inc.. It received FDA 510(k) clearance on 2022-10-24 under 510(k) 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. The listed applicant is Pega Medical, Inc.. The 510(k) number is K220190.

When did The GIRO Growth Modulation System receive FDA 510(k) clearance?

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

Who is the listed applicant for The GIRO Growth Modulation System?

The FDA 510(k) record lists Pega Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Pega Medical, Inc. as applicant

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Related Devices (Code: OBT)

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.

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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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