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FDA 510(k)

BonOs Inject Bone Cement; NEO Pedicle Screw System

K-Number: K212489 · 2021-10-28

ApplicantNeo Medical SA
Decision Date2021-10-28
Product CodePML
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BonOs Inject Bone Cement; NEO Pedicle Screw System is a medical device manufactured by Neo Medical SA. It received FDA 510(k) clearance on 2021-10-28 under approval number K212489. The device is classified under product code PML. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BonOs Inject Bone Cement; NEO Pedicle Screw System?

BonOs Inject Bone Cement; NEO Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2021-10-28. It is manufactured by Neo Medical SA. The 510(k) number is K212489.

When was BonOs Inject Bone Cement; NEO Pedicle Screw System approved by the FDA?

BonOs Inject Bone Cement; NEO Pedicle Screw System received FDA 510(k) clearance on 2021-10-28, under approval number K212489.

What company makes BonOs Inject Bone Cement; NEO Pedicle Screw System?

BonOs Inject Bone Cement; NEO Pedicle Screw System is manufactured by Neo Medical SA.

What is the FDA product code for BonOs Inject Bone Cement; NEO Pedicle Screw System?

The FDA product code for BonOs Inject Bone Cement; NEO Pedicle Screw System is PML.

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 NCT07408726 Monoaxial vs. Polyaxial Percutaneous Hybrid Stabilization NOT_YET_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)

Other Devices by Neo Medical SA

K171582NEO Pedicle Screw System™ K191796Neo Cage System K181048Neo Cage System TM K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™ K243693NEO Pedicle Screw System™

Related Devices (Code: PML)

K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw SystemGlobus Medical, Inc. K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics , Ltd.

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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