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FDA 510(k)

Delphos Implants Rigid Fixation System

K-Number: K182609 · 2019-03-29

ApplicantDelphos Implants - Ind.Com. Importacao E Exportacao DE
Decision Date2019-03-29
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Delphos Implants Rigid Fixation System is a medical device manufactured by Delphos Implants - Ind.Com. Importacao E Exportacao DE. It received FDA 510(k) clearance on 2019-03-29 under approval number K182609. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Delphos Implants Rigid Fixation System?

Delphos Implants Rigid Fixation System is a medical device that received FDA 510(k) clearance on 2019-03-29. It is manufactured by Delphos Implants - Ind.Com. Importacao E Exportacao DE. The 510(k) number is K182609.

When was Delphos Implants Rigid Fixation System approved by the FDA?

Delphos Implants Rigid Fixation System received FDA 510(k) clearance on 2019-03-29, under approval number K182609.

What company makes Delphos Implants Rigid Fixation System?

Delphos Implants Rigid Fixation System is manufactured by Delphos Implants - Ind.Com. Importacao E Exportacao DE.

What is the FDA product code for Delphos Implants Rigid Fixation System?

The FDA product code for Delphos Implants Rigid Fixation System is JEY.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT06423378 Bio-Integrative, Fiber-Reinforced Kneebar for Treating Subchondral Insufficiency of the Knee ENROLLING_BY_INVITATION NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT05883202 Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants SUSPENDED NCT07574632 A Study to Evaluate a New Semi-rigid Brace, the RESILIENT Brace by Thinks Works, as a Way to Limit Curve Worsening in Kids With Idiopathic Scoliosis. NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Related Devices (Code: JEY)

K160363OPTIMUS CMF SYSTEMOsteonic Co., Ltd. K163579KLS Martin Individual Patient SolutionsKLS Martin L.P. K170773Stryker Universal MeshStryker K172572Stryker Upper-Face AXS screws and Mid-Face AXS screwsStryker K170272TruMatch CMF Titanium 3D Printed Implant SystemMaterialise NV K171364MP LeFort I PlatesStryker

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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