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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 the device name listed in this FDA 510(k) record. The listed applicant is OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2025-03-14 under 510(k) 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. The listed applicant is OrthoPediatrics Corp.. The 510(k) number is K241816.

When did VerteGlide Spinal Growth Guidance System receive FDA 510(k) clearance?

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

Who is the listed applicant for VerteGlide Spinal Growth Guidance System?

The FDA 510(k) record lists OrthoPediatrics Corp. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing OrthoPediatrics Corp. as applicant

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Related Devices (Code: PGM)

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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