Skip to content

NET Brand Osteosynthesis Nailing System

by Narang Medical, Ltd. India 510(k)

510(k) K233150 Product code JDS

Overview

The NET Brand Osteosynthesis Nailing System is a metallic intramedullary fixation device classified as a Bone Fixation Nail (product code JDS). It consists of intramedullary nails, locking screws, and bolts designed to stabilize long bone fractures, such as those of the tibia or femur, by providing internal mechanical support during the healing process. This device functions as an internal splint to maintain proper bone alignment, aiding in the restoration of structural integrity and facilitating skeletal recovery.

Intended for use in clinical and surgical settings by orthopedic surgeons, the system is supplied as a sterile, single-use device. It is regulated under FDA 510(k) clearance (K233150) and falls under Class II special controls for orthopedic applications. The system includes multiple nail sizes and configurations, as referenced by the listed FEI numbers, ensuring compatibility with various fracture patterns and anatomical requirements. Storage and handling follow standard sterile medical device protocols to maintain integrity prior to use.

Summary written by AI from registry data, 1 Oct 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK233150 Date20 Feb 2024ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
JDS
FDA applicant
Narang Medical , Ltd.
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Narang Medical, Ltd.

  • Net

    Class I

  • Net

    Class I

  • Net

    Class I

  • Net

    Class I

  • Net

    Class I

  • Net

    Class I

See all devices from Narang Medical, Ltd. →

Questions

  • What is the NET Brand Osteosynthesis Nailing System used for?

    The NET Brand Osteosynthesis Nailing System is designed to stabilize long bone fractures, such as those in the tibia or femur. It functions as an internal mechanical support, maintaining proper bone alignment during the healing process. This helps restore structural integrity and facilitates skeletal recovery by acting as an internal splint.

  • Is the NET Brand Osteosynthesis Nailing System sterile and single-use?

    Yes, the NET Brand Osteosynthesis Nailing System is supplied as a sterile, single-use device. This ensures patient safety and reduces the risk of infection by preventing reuse, which is critical for maintaining sterility and compliance with medical device standards.

  • What sizes and configurations are available in the NET Brand Osteosynthesis Nailing System?

    The system includes a variety of intramedullary nail sizes and configurations, each referenced by unique FEI numbers (e.g., 3002806685, 1000306431). These variations allow compatibility with different fracture patterns and anatomical requirements, ensuring versatility for clinical use.

  • How should the NET Brand Osteosynthesis Nailing System be stored?

    The system must be stored following standard sterile medical device protocols to preserve its integrity before use. This includes maintaining proper packaging, avoiding contamination, and adhering to manufacturer guidelines for shelf life and environmental conditions to ensure effectiveness and safety.

  • What regulatory approval does the NET Brand Osteosynthesis Nailing System hold?

    The NET Brand Osteosynthesis Nailing System holds FDA 510(k) clearance under the classification of Bone Fixation Nail (product code JDS). This clearance indicates that the device meets FDA standards for safety and effectiveness as a Class II medical device under special controls for orthopedic applications.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K233150 24 fields · synced 22 Oct 2026