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NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System

by Narang Medical Limited

510(k) K150561

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K150561↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK150561 Date25 Nov 2015ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Full name
NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System
510(k) Number
FDA Product Code
HRS
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System is a Plate, Fixation, Bone (per FDA classification HRS) designed for internal fixation of bone fractures. It stabilises fragments through locking and non-locking plates, screws, and other fixation hardware, enabling bone alignment and union in complex fractures, arthrodesis, and osteotomies. Applications include clavicle, scapula, humerus, olecranon, radius, ulna, distal femur, proximal tibia, fibula, pelvis, acetabulum, and periprosthetic fractures. The system combines modular components for versatility in surgical approaches.

This system is supplied sterile and intended for single-use, adhering to FDA 510(k) clearance (K150561) and EU MDR compliance. It is intended for use in orthopaedic surgery settings, with components available in standard sizes for small and large fragment fixation. Storage requires protection from moisture and mechanical damage, and the device must be handled in accordance with sterile surgical protocols. No MRI safety information is specified in the regulatory data.

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Questions

AI-generated answers, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of bone fractures and surgical procedures is this plating system designed to address in the orthopedic setting?

    This system is specifically designed for internal fixation of complex fractures, arthrodesis (joint fusion), and osteotomies (controlled bone cuts) across multiple skeletal sites. It stabilizes bone fragments using locking and non-locking plates, screws, and modular hardware, making it suitable for clavicle, scapula, humerus, forearm (radius/ulna), elbow (olecranon), distal femur, proximal tibia, fibula, pelvis, acetabulum, and periprosthetic fractures. The modular components allow versatility to adapt to various surgical approaches and anatomical challenges.

  • Is this plating system intended for reuse, or is it meant to be used only once per patient?

    The NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System is explicitly intended for single-use only. This is reinforced by its sterile packaging and compliance with FDA 510(k) clearance (K150561), which mandates adherence to single-use standards for orthopedic fixation hardware to ensure patient safety and sterility.

  • How should I store this device to maintain its integrity before use in surgery?

    The device must be stored in a dry environment, protected from moisture and mechanical damage, to preserve its sterility and functionality. Since it is supplied sterile and intended for single-use, it should be handled according to standard sterile surgical protocols—never opened or exposed to non-sterile conditions until immediately before use. Avoid exposure to extreme temperatures or humidity.

  • What regulatory pathways does this device follow, and how does that affect its use in the U.S. and EU?

    This system follows FDA 510(k) clearance (K150561) for the U.S. market, demonstrating substantial equivalence to a predicate device under the Traditional review pathway. In the EU, it complies with MDR (Medical Device Regulation), ensuring conformity with European safety and performance standards. Both pathways confirm its suitability for internal fixation in orthopedic surgery, but clinicians should verify local hospital protocols for specific procedural integration.