Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is CarboFix Orthopedics , Ltd.. It received FDA 510(k) clearance on 2016-01-06 under 510(k) 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. The listed applicant is CarboFix Orthopedics , Ltd.. The 510(k) number is K153536.

When did Piccolo Composite® Nailing System receive FDA 510(k) clearance?

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

Who is the listed applicant for Piccolo Composite® Nailing System?

The FDA 510(k) record lists CarboFix Orthopedics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing CarboFix Orthopedics , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw SystemK243106CarboClear® Hybrid Pedicle Screw SystemK233793CarboClear® X Pedicle Screw SystemK240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone CementK233989CarboClear® Posterior Cervical Screw SystemK233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments

View all 25 devices →

Related Devices (Code: HSB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261481Pangea Femur Reconstruction SystemStryker GmbHK261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.K260146FITBONE® TRANSPORT AND LENGTHENING SYSTEMOrthofix Srl

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.

↑