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)

Sternal Cable System

K-Number: K193479 · 2020-03-23

ApplicantA & E Medical Corporation
Decision Date2020-03-23
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Sternal Cable 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 2020-03-23 under 510(k) number K193479. 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 Sternal Cable System?

Sternal Cable System is a medical device that received FDA 510(k) clearance on 2020-03-23. The listed applicant is A & E Medical Corporation. The 510(k) number is K193479.

When did Sternal Cable System receive FDA 510(k) clearance?

Sternal Cable System received FDA 510(k) clearance on 2020-03-23, under 510(k) number K193479.

Who is the listed applicant for Sternal Cable 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 Sternal Cable System?

The FDA product code for Sternal Cable 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.

K181607Thorecon Rigid Fixation SystemK180582Sternal Cable SystemK173579Thorecon™ Fixation 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.

↑