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FDA 510(k)

Piccolo Composite(R) Distal Volar Radius Plate System

K-Number: K160002 · 2016-03-09

ApplicantCarboFix Orthopedics , Ltd.
Decision Date2016-03-09
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Piccolo Composite(R) Distal Volar Radius Plate System is a medical device manufactured by CarboFix Orthopedics , Ltd.. It received FDA 510(k) clearance on 2016-03-09 under approval number K160002. 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(R) Distal Volar Radius Plate System?

Piccolo Composite(R) Distal Volar Radius Plate System is a medical device that received FDA 510(k) clearance on 2016-03-09. It is manufactured by CarboFix Orthopedics , Ltd.. The 510(k) number is K160002.

When was Piccolo Composite(R) Distal Volar Radius Plate System approved by the FDA?

Piccolo Composite(R) Distal Volar Radius Plate System received FDA 510(k) clearance on 2016-03-09, under approval number K160002.

What company makes Piccolo Composite(R) Distal Volar Radius Plate System?

Piccolo Composite(R) Distal Volar Radius Plate System is manufactured by CarboFix Orthopedics , Ltd..

What is the FDA product code for Piccolo Composite(R) Distal Volar Radius Plate System?

The FDA product code for Piccolo Composite(R) Distal Volar Radius 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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