510(k) Report

FDA applicant

N.M.B. Medical Applications, Ltd.

Herzliya, IL4 decisions2010–20111 recall

FDA records 4 decisions for N.M.B. Medical Applications, Ltd. (Herzliya, IL) from 2010 to 2011: 4 510(k) clearances. Most are in product codes HSB (Rod, Fixation, Intramedullary And Accessories) and HRS (Plate, Fixation, Bone). Its devices cite 35 predicates, 5 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided N.M.B. Medical Applications, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2011

2010: 22011: 2
2010high 2 (2010) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2016

2016: 1
2010high 1 (2016) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — N.M.B. Medical Applications, Ltd. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like N.M.B. Medical Applications, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • HSBRod, Fixation, Intramedullary And Accessories3decisions
  • HRSPlate, Fixation, Bone1decision

Whose devices does it build on?

Its devices cite 35 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 25 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd. · 20118cite it
  • K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 20107cite it
  • K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 20105cite it
  • K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 20115cite it

What has FDA decided for it lately?

  • K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd. · 2011
  • K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 20111 recall
  • K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010
  • K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010

All 4 as N.M.B. Medical Applications, Ltd. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K102369Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire for fixation…May 10, 2016Class II