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FDA 510(k)

OrthoPediatrics® Locking Cannulated Blade Plate System

K-Number: K260323 · 2026-04-30

Decision Date2026-04-30
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OrthoPediatrics® Locking Cannulated Blade Plate 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 2026-04-30 under 510(k) number K260323. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OrthoPediatrics® Locking Cannulated Blade Plate System?

OrthoPediatrics® Locking Cannulated Blade Plate System is a medical device that received FDA 510(k) clearance on 2026-04-30. The listed applicant is OrthoPediatrics Corp.. The 510(k) number is K260323.

When did OrthoPediatrics® Locking Cannulated Blade Plate System receive FDA 510(k) clearance?

OrthoPediatrics® Locking Cannulated Blade Plate System received FDA 510(k) clearance on 2026-04-30, under 510(k) number K260323.

Who is the listed applicant for OrthoPediatrics® Locking Cannulated Blade Plate 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 OrthoPediatrics® Locking Cannulated Blade Plate System?

The FDA product code for OrthoPediatrics® Locking Cannulated Blade Plate System is HRS.

Other records listing OrthoPediatrics Corp. as applicant

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.

View all 27 devices →

Related Devices (Code: HRS)

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.

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.