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FDA 510(k)

Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur

K-Number: K250623 · 2025-04-01

ApplicantOrthoPediatrics Corp.
Decision Date2025-04-01
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur is a medical device manufactured by OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2025-04-01 under approval number K250623. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur?

Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur is a medical device that received FDA 510(k) clearance on 2025-04-01. It is manufactured by OrthoPediatrics Corp.. The 510(k) number is K250623.

When was Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur approved by the FDA?

Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur received FDA 510(k) clearance on 2025-04-01, under approval number K250623.

What company makes Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur?

Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur is manufactured by OrthoPediatrics Corp..

What is the FDA product code for Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur?

The FDA product code for Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur is HSB.

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Other Devices by OrthoPediatrics Corp.

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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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