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Quantum IM Composite Nailing System (Quantum Nailing System)

by N.M.B. Medical Applications, Ltd. 510(k)

Active United States

510(k) K100497

Overview

The Quantum IM Composite Nailing System (Quantum Nailing System) is an orthopedic device designed for intramedullary nailing procedures. It is a composite-based implant system intended for the stabilization of long bone fractures.

The device is supplied as a sterile, single-use implant system and is indicated for use in orthopedic surgical settings. It has received FDA 510(k) clearance (K100497) and is classified under product code HSB. The system is manufactured by N.M.B. Medical Applications, Ltd. and is intended for use in accordance with its labeling and regulatory authorization.

AI-generated from registry data, 23 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK100497 Date21 Jun 2010ClearedStatusActive

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

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HSB
Device Class
Class II
Regulation
21 CFR Part 888.3020
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from N.M.B. Medical Applications, Ltd.

Questions

  • What is the Quantum IM Composite Nailing System used for?

    The Quantum IM Composite Nailing System is an orthopedic device designed for intramedullary nailing procedures, specifically intended for the stabilization of long bone fractures in surgical settings.

  • How is the Quantum IM Composite Nailing System supplied and is it reusable?

    The device is supplied as a sterile, single-use implant system, meaning each unit is intended for one procedure only and must not be reprocessed or reused to maintain sterility and structural integrity.

  • What regulatory clearance does the Quantum IM Composite Nailing System have?

    The system has received FDA 510(k) clearance under submission number K100497 and is classified under product code HSB, indicating it was found substantially equivalent to a legally marketed predicate device.