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® 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 the device name listed in this FDA 510(k) record. The listed applicant is CarboFix Orthopedics , Ltd.. It received FDA 510(k) clearance on 2017-05-12 under 510(k) 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. The listed applicant is CarboFix Orthopedics , Ltd.. The 510(k) number is K170401.

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

Piccolo Composite® Plate System received FDA 510(k) clearance on 2017-05-12, under 510(k) number K170401.

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

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

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: HRS)

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.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

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.

↑