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FDA 510(k)

Stern Fix Sternal Stabilization System

K-Number: K211613 · 2022-01-19

ApplicantNeos Surgery S.L
Decision Date2022-01-19
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Stern Fix Sternal Stabilization System is the device name listed in this FDA 510(k) record. The listed applicant is Neos Surgery S.L. It received FDA 510(k) clearance on 2022-01-19 under 510(k) number K211613. 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 Stern Fix Sternal Stabilization System?

Stern Fix Sternal Stabilization System is a medical device that received FDA 510(k) clearance on 2022-01-19. The listed applicant is Neos Surgery S.L. The 510(k) number is K211613.

When did Stern Fix Sternal Stabilization System receive FDA 510(k) clearance?

Stern Fix Sternal Stabilization System received FDA 510(k) clearance on 2022-01-19, under 510(k) number K211613.

Who is the listed applicant for Stern Fix Sternal Stabilization System?

The FDA 510(k) record lists Neos Surgery S.L as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stern Fix Sternal Stabilization System?

The FDA product code for Stern Fix Sternal Stabilization System is JDQ.

Other records listing Neos Surgery S.L 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.

K240137Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation SystemK221795STERN FIX Sternal Stabilization SystemK160739Cranial COVER

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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