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FDA 510(k)

VerteGlide Spinal Growth Guidance System

K-Number: K241816 · 2025-03-14

ApplicantOrthoPediatrics Corp.
Decision Date2025-03-14
Product CodePGM
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VerteGlide Spinal Growth Guidance System is a medical device manufactured by OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2025-03-14 under approval number K241816. The device is classified under product code PGM. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VerteGlide Spinal Growth Guidance System?

VerteGlide Spinal Growth Guidance System is a medical device that received FDA 510(k) clearance on 2025-03-14. It is manufactured by OrthoPediatrics Corp.. The 510(k) number is K241816.

When was VerteGlide Spinal Growth Guidance System approved by the FDA?

VerteGlide Spinal Growth Guidance System received FDA 510(k) clearance on 2025-03-14, under approval number K241816.

What company makes VerteGlide Spinal Growth Guidance System?

VerteGlide Spinal Growth Guidance System is manufactured by OrthoPediatrics Corp..

What is the FDA product code for VerteGlide Spinal Growth Guidance System?

The FDA product code for VerteGlide Spinal Growth Guidance System is PGM.

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Related Devices (Code: PGM)

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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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