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FDA 510(k)

Breakaway Screw System

K-Number: K172886 · 2017-12-20

ApplicantParagon 28
Decision Date2017-12-20
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Breakaway Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Paragon 28. It received FDA 510(k) clearance on 2017-12-20 under 510(k) number K172886. 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 Breakaway Screw System?

Breakaway Screw System is a medical device that received FDA 510(k) clearance on 2017-12-20. The listed applicant is Paragon 28. The 510(k) number is K172886.

When did Breakaway Screw System receive FDA 510(k) clearance?

Breakaway Screw System received FDA 510(k) clearance on 2017-12-20, under 510(k) number K172886.

Who is the listed applicant for Breakaway Screw System?

The FDA 510(k) record lists Paragon 28 as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Breakaway Screw System?

The FDA product code for Breakaway Screw System is HRS.

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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.

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