Piccolo Composite® Plate System
K-Number: K170401 · 2017-05-12
ApplicantCarboFix Orthopedics , Ltd.
Decision Date2017-05-12
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Piccolo Composite® Plate System is a medical device manufactured by CarboFix Orthopedics , Ltd.. It received FDA 510(k) clearance on 2017-05-12 under approval number K170401. 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® Plate System?
Piccolo Composite® Plate System is a medical device that received FDA 510(k) clearance on 2017-05-12. It is manufactured by CarboFix Orthopedics , Ltd.. The 510(k) number is K170401.
When was Piccolo Composite® Plate System approved by the FDA?
Piccolo Composite® Plate System received FDA 510(k) clearance on 2017-05-12, under approval number K170401.
What company makes Piccolo Composite® Plate System?
Piccolo Composite® Plate System is manufactured by CarboFix Orthopedics , Ltd..
What is the FDA product code for Piccolo Composite® Plate System?
The FDA product code for Piccolo Composite® Plate System is 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.