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FDA 510(k)

Piccolo Composite® Nailing System

K-Number: K153536 · 2016-01-06

ApplicantCarboFix Orthopedics , Ltd.
Decision Date2016-01-06
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Piccolo Composite® Nailing System is a medical device manufactured by CarboFix Orthopedics , Ltd.. It received FDA 510(k) clearance on 2016-01-06 under approval number K153536. 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 Piccolo Composite® Nailing System?

Piccolo Composite® Nailing System is a medical device that received FDA 510(k) clearance on 2016-01-06. It is manufactured by CarboFix Orthopedics , Ltd.. The 510(k) number is K153536.

When was Piccolo Composite® Nailing System approved by the FDA?

Piccolo Composite® Nailing System received FDA 510(k) clearance on 2016-01-06, under approval number K153536.

What company makes Piccolo Composite® Nailing System?

Piccolo Composite® Nailing System is manufactured by CarboFix Orthopedics , Ltd..

What is the FDA product code for Piccolo Composite® Nailing System?

The FDA product code for Piccolo Composite® Nailing System is HSB.

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Other Devices by CarboFix Orthopedics , Ltd.

K160002Piccolo Composite(R) Distal Volar Radius Plate System K173652Piccolo Composite Nailing System K170401Piccolo Composite® Plate System K182015Piccolo Composite® Plate System K182377CarboClear® Pedicle Screw System K173487CarboClear® Pedicle Screw System

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Related Devices (Code: HSB)

K161264TRIGEN Low Profile Bone ScrewsSmith & Nephew, Inc. K160545GAP ENDO-EXO MEDULLARY SYSTEMPega Medical, Inc. K161254Renovo Life Small Bone IM Nail SystemRenovo Life, LLC K160167DePuy Synthes TFNA Augmentation SystemSynthes (USA) Products, LLC K160325PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. K160267PRECICE Trauma Nail SystemEllipse Technologies, Incorporated

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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