Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Whistler Modular Pedicle Screw System

K-Number: K182478 · 2019-01-15

ApplicantEvolution Spine, LLC
Decision Date2019-01-15
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Whistler Modular Pedicle Screw System is a medical device manufactured by Evolution Spine, LLC. It received FDA 510(k) clearance on 2019-01-15 under approval number K182478. 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 Whistler Modular Pedicle Screw System?

Whistler Modular Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2019-01-15. It is manufactured by Evolution Spine, LLC. The 510(k) number is K182478.

When was Whistler Modular Pedicle Screw System approved by the FDA?

Whistler Modular Pedicle Screw System received FDA 510(k) clearance on 2019-01-15, under approval number K182478.

What company makes Whistler Modular Pedicle Screw System?

Whistler Modular Pedicle Screw System is manufactured by Evolution Spine, LLC.

What is the FDA product code for Whistler Modular Pedicle Screw System?

The FDA product code for Whistler Modular 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 NCT04798768 Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing ACTIVE_NOT_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT04358601 All-poly Versus Metal-backed ACTIVE_NOT_RECRUITING 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

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)

Other Devices by Evolution Spine, LLC

K160663Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF) K160324Cervical Interbody Fusion System K173375Anterior Cervical Plate System K180755Vail ALIF Buttress Plate System

Related Devices (Code: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, 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.

↑