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FDA 510(k)

Pediatric Nailing PlatformFemur

K-Number: K190321 · 2019-10-09

ApplicantOrthoPediatrics Corp.
Decision Date2019-10-09
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Pediatric Nailing PlatformFemur is a medical device manufactured by OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2019-10-09 under approval number K190321. 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 PlatformFemur?

Pediatric Nailing PlatformFemur is a medical device that received FDA 510(k) clearance on 2019-10-09. It is manufactured by OrthoPediatrics Corp.. The 510(k) number is K190321.

When was Pediatric Nailing PlatformFemur approved by the FDA?

Pediatric Nailing PlatformFemur received FDA 510(k) clearance on 2019-10-09, under approval number K190321.

What company makes Pediatric Nailing PlatformFemur?

Pediatric Nailing PlatformFemur is manufactured by OrthoPediatrics Corp..

What is the FDA product code for Pediatric Nailing PlatformFemur?

The FDA product code for Pediatric Nailing PlatformFemur 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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