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)

NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate

K-Number: K241754 · 2024-08-15

ApplicantZimmer Switzerland Manufacturing GmbH
Decision Date2024-08-15
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate is a medical device manufactured by Zimmer Switzerland Manufacturing GmbH. It received FDA 510(k) clearance on 2024-08-15 under approval number K241754. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate?

NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate is a medical device that received FDA 510(k) clearance on 2024-08-15. It is manufactured by Zimmer Switzerland Manufacturing GmbH. The 510(k) number is K241754.

When was NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate approved by the FDA?

NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate received FDA 510(k) clearance on 2024-08-15, under approval number K241754.

What company makes NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate?

NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate is manufactured by Zimmer Switzerland Manufacturing GmbH.

What is the FDA product code for NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate?

The FDA product code for NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate is HRS.

Related Clinical Trials

NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT06297291 Global Paradise System US Post Approval Study RECRUITING NCT07560891 LBBAP vs. CS Pacing for CRT in Permanent Atrial Fibrillation and Heart Failure (SYNC-AF) NOT_YET_RECRUITING NCT05467163 Conduction System Pacing Versus Biventricular Pacing After Atrioventricular Node Ablation ACTIVE_NOT_RECRUITING NCT04015128 A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail GT ACTIVE_NOT_RECRUITING

Other Devices by Zimmer Switzerland Manufacturing GmbH

K212129Persona® Personalized Knee System K231114Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System K253749Affixus® Natural Nail® Proximal Humeral System

Related Devices (Code: HRS)

K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc. K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate AG

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.

↑