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FDA 510(k)

Pediatric Nailing Platform Tibia

K-Number: K231266 · 2023-08-21

ApplicantOrthoPediatrics Corp.
Decision Date2023-08-21
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Pediatric Nailing Platform Tibia is a medical device manufactured by OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2023-08-21 under approval number K231266. 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 Tibia is a medical device that received FDA 510(k) clearance on 2023-08-21. It is manufactured by OrthoPediatrics Corp.. The 510(k) number is K231266.

When was Pediatric Nailing Platform Tibia approved by the FDA?

Pediatric Nailing Platform Tibia received FDA 510(k) clearance on 2023-08-21, under approval number K231266.

What company makes Pediatric Nailing Platform Tibia?

Pediatric Nailing Platform Tibia is manufactured by OrthoPediatrics Corp..

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

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

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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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