510(k) Report

FDA applicant

Efratgo, Ltd. HI Tech Bio-Surgical

Somerset, MA3 decisions1999–20090 recalls

FDA records 3 decisions for Efratgo, Ltd. HI Tech Bio-Surgical (Somerset, MA) from 1999 to 2009: 3 510(k) clearances. Most are in product codes HSB (Rod, Fixation, Intramedullary And Accessories) and JDO (Device, Fixation, Proximal Femoral, Implant). Its devices cite 8 predicates, 2 of them its own earlier devices. No 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 Efratgo, Ltd. HI Tech Bio-Surgical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Efratgo, Ltd. HI Tech Bio-Surgical by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Efratgo, Ltd. HI Tech Bio-Surgical’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • HSBRod, Fixation, Intramedullary And Accessories2decisions
  • JDODevice, Fixation, Proximal Femoral, Implant1decision

Whose devices does it build on?

Its devices cite 8 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 2 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.

  • K983814Gotfried Percutaneous Compression Plating SystemEfratgo, Ltd. HI Tech Bio-Surgical · 19993cite it
  • K043233Gotfried Physiological Hip (PH) NailEfratgo, Ltd. HI Tech Bio-Surgical · 20051cites it

What has FDA decided for it lately?

  • K083648Gotfried Physiological Hip (PH) NailEfratgo, Ltd. HI Tech Bio-Surgical · 2009
  • K043233Gotfried Physiological Hip (PH) NailEfratgo, Ltd. HI Tech Bio-Surgical · 2005
  • K983814Gotfried Percutaneous Compression Plating SystemEfratgo, Ltd. HI Tech Bio-Surgical · 1999

All 3 as Efratgo, Ltd. HI Tech Bio-Surgical →