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FDA 510(k)

Thorecon™ Fixation System

K-Number: K173579 · 2018-02-12

ApplicantA & E Medical Corporation
Decision Date2018-02-12
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Thorecon™ Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is A & E Medical Corporation. It received FDA 510(k) clearance on 2018-02-12 under 510(k) number K173579. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Thorecon™ Fixation System?

Thorecon™ Fixation System is a medical device that received FDA 510(k) clearance on 2018-02-12. The listed applicant is A & E Medical Corporation. The 510(k) number is K173579.

When did Thorecon™ Fixation System receive FDA 510(k) clearance?

Thorecon™ Fixation System received FDA 510(k) clearance on 2018-02-12, under 510(k) number K173579.

Who is the listed applicant for Thorecon™ Fixation System?

The FDA 510(k) record lists A & E Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Thorecon™ Fixation System?

The FDA product code for Thorecon™ Fixation System is JDQ.

Other records listing A & E Medical Corporation 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.

K193479Sternal Cable SystemK181607Thorecon Rigid Fixation SystemK180582Sternal Cable System

Related Devices (Code: JDQ)

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.

K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage SuturesArthrex, Inc.K232733Mbrace CableMedacta International S.A.K233949ACCORD Cable SystemSmith & Nephew, Inc.K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.

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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