510(k) Report

FDA applicant

Unitedstates Surgical

Norwalk, CT2 decisions2002–20020 recalls

FDA records 2 decisions for Unitedstates Surgical (Norwalk, CT) in 2002: 2 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and KWP (Appliance, Fixation, Spinal Interlaminal). 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 Unitedstates Surgical’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Unitedstates Surgical since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Unitedstates Surgical 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?

  • HWCScrew, Fixation, Bone1decision
  • KWPAppliance, Fixation, Spinal Interlaminal1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K020352Surgical Dynamics Ogden Suture Anchor with SutureUnitedstates Surgical · 20021cites it

What has FDA decided for it lately?

  • K021825Modification to Spiral Radius 90-D SST SystemUnitedstates Surgical · 2002
  • K020352Surgical Dynamics Ogden Suture Anchor with SutureUnitedstates Surgical · 2002

All 2 as Unitedstates Surgical →