510(k) Report

FDA applicant

Surgical Implant Generation Network (Sign)

Richland, WA4 decisions2001–20090 recalls

FDA records 4 decisions for Surgical Implant Generation Network (Sign) (Richland, WA) from 2001 to 2009: 4 510(k) clearances. Most are in product codes HSB (Rod, Fixation, Intramedullary And Accessories) and KTT (Appliance, Fixation, Nail/Blade/Plate…). Its devices cite 9 predicates, 1 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 Surgical Implant Generation Network (Sign)’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 — Surgical Implant Generation Network (Sign) by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HSBRod, Fixation, Intramedullary And Accessories3decisions
  • KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component1decision

Whose devices does it build on?

Its devices cite 9 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 1 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.

  • K083582Sign Hip Construct (SHC), Model: 701Surgical Implant Generation Network (Sign) · 20092cite it
  • K043200Sign Fin NailSurgical Implant Generation Network (Sign) · 20052cite it
  • K022632Sign IM NailSurgical Implant Generation Network (Sign) · 20022cite it

What has FDA decided for it lately?

  • K083582Sign Hip Construct (SHC), Model: 701Surgical Implant Generation Network (Sign) · 2009
  • K043200Sign Fin NailSurgical Implant Generation Network (Sign) · 2005
  • K022632Sign IM NailSurgical Implant Generation Network (Sign) · 2002
  • K013132Sign IM NailSurgical Implant Generation Network (Sign) · 2001

All 4 as Surgical Implant Generation Network (Sign) →