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FDA 510(k)

Elaris Pedicle Screw System

K-Number: K183091 · 2019-08-02

ApplicantSpinewelding AG
Decision Date2019-08-02
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Elaris Pedicle Screw System is a medical device manufactured by Spinewelding AG. It received FDA 510(k) clearance on 2019-08-02 under approval number K183091. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Elaris Pedicle Screw System?

Elaris Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2019-08-02. It is manufactured by Spinewelding AG. The 510(k) number is K183091.

When was Elaris Pedicle Screw System approved by the FDA?

Elaris Pedicle Screw System received FDA 510(k) clearance on 2019-08-02, under approval number K183091.

What company makes Elaris Pedicle Screw System?

Elaris Pedicle Screw System is manufactured by Spinewelding AG.

What is the FDA product code for Elaris Pedicle Screw System?

The FDA product code for Elaris Pedicle Screw System is NKB.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED NCT06720948 The ION Facet Screw System Ambispective Evaluation ENROLLING_BY_INVITATION NCT06960018 Clinical Study on the Safety and Efficacy of the Minimally Invasive Ennovate® Method for Pedicle Screw Placement RECRUITING

Related PubMed Literature

PMID: 41487949 Verification, validation, and uncertainty quantification of finite element analysis results for pedicle screw assemblies under ASTM F1717 flexion and extension testing. Frontiers in bioengineering and biotechnology (2025)

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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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