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FDA 510(k)

STERN FIX Sternal Stabilization System

K-Number: K221795 · 2022-10-19

ApplicantNeos Surgery S.L
Decision Date2022-10-19
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STERN FIX Sternal Stabilization System is a medical device manufactured by Neos Surgery S.L. It received FDA 510(k) clearance on 2022-10-19 under approval number K221795. 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 2022-10-19. It is manufactured by Neos Surgery S.L. The 510(k) number is K221795.

When was STERN FIX Sternal Stabilization System approved by the FDA?

STERN FIX Sternal Stabilization System received FDA 510(k) clearance on 2022-10-19, under approval number K221795.

What company makes STERN FIX Sternal Stabilization System?

STERN FIX Sternal Stabilization System is manufactured by Neos Surgery S.L.

What is the FDA product code for STERN FIX Sternal Stabilization System?

The FDA product code for STERN FIX Sternal Stabilization System is JDQ.

Related Clinical Trials

NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED NCT07251881 SuperCable vs. Conventional Steel Wire for Closure After a Median Sternotomy NOT_YET_RECRUITING NCT07485829 Zimmer Biomet-RibFix Titan RECRUITING NCT05206981 Device Global Registry for the IlluminOss Bone Stabilization System RECRUITING NCT06939374 Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study RECRUITING

Other Devices by Neos Surgery S.L

K160739Cranial COVER K211613Stern Fix Sternal Stabilization System K240137Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System

Related Devices (Code: JDQ)

K161876Tritium® Sternal Cable Plate SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. K151983KLS Martin LSS Plating SystemKLS Martin L.P. K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc. K153242Frontier Medical Devices In-Line Orthopedic Cable Cerclage SystemFrontier Medical Devices, Inc. K170206Arthrex FiberTape CerclageArthrex, Inc. K181607Thorecon Rigid Fixation SystemA & E Medical Corporation

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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