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FDA 510(k)

Piccolo Composite Proximal Tibia Plate System

K-Number: K201917 · 2020-10-08

ApplicantCarboFix Orthopedics , Ltd.
Decision Date2020-10-08
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Piccolo Composite Proximal Tibia Plate System is a medical device manufactured by CarboFix Orthopedics , Ltd.. It received FDA 510(k) clearance on 2020-10-08 under approval number K201917. 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 Piccolo Composite Proximal Tibia Plate System?

Piccolo Composite Proximal Tibia Plate System is a medical device that received FDA 510(k) clearance on 2020-10-08. It is manufactured by CarboFix Orthopedics , Ltd.. The 510(k) number is K201917.

When was Piccolo Composite Proximal Tibia Plate System approved by the FDA?

Piccolo Composite Proximal Tibia Plate System received FDA 510(k) clearance on 2020-10-08, under approval number K201917.

What company makes Piccolo Composite Proximal Tibia Plate System?

Piccolo Composite Proximal Tibia Plate System is manufactured by CarboFix Orthopedics , Ltd..

What is the FDA product code for Piccolo Composite Proximal Tibia Plate System?

The FDA product code for Piccolo Composite Proximal Tibia Plate System is HRS.

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Other Devices by CarboFix Orthopedics , Ltd.

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Related Devices (Code: HRS)

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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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