510(k) Report

FDA applicant

Warsaw Orthopedic, Inc.

Warsaw, IN24 decisions1983–19890 recalls

FDA records 24 decisions for Warsaw Orthopedic, Inc. (Warsaw, IN) from 1983 to 1989: 24 510(k) clearances. Most are in product codes KWP (Appliance, Fixation, Spinal Interlaminal) and KTT (Appliance, Fixation, Nail/Blade/Plate…). 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 Warsaw Orthopedic, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Warsaw Orthopedic, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Warsaw Orthopedic, Inc. 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?

  • KWPAppliance, Fixation, Spinal Interlaminal6decisions
  • KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component2decisions
  • HWRDriver, Prosthesis2decisions
  • KTWAppliance, Fixation, Nail/Blade/Plate Combination, Single Component1decision
  • HWBExtractor1decision
  • HWCScrew, Fixation, Bone1decision

Also: HWP (1), LYQ (1), HTO (1), HSB (1), JDR (1), FNJ (1).

Who builds on its devices?

Later devices cite its devices 3 times; 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.

  • K880215TSRH H/M Hook, Eyebolt/Lock Nut Assem., Spinal RodWarsaw Orthopedic, Inc. · 19883cite it

What has FDA decided for it lately?

  • K892877Cradle, Hospital Bed ClothingWarsaw Orthopedic, Inc. · 1989
  • K883783TSRH Sacral Spinal ScrewWarsaw Orthopedic, Inc. · 1989
  • K883784TSRH Anterior Spinal Screws, Staples and End PlateWarsaw Orthopedic, Inc. · 1989
  • K880211TSRH H/M Hook HolderWarsaw Orthopedic, Inc. · 1988
  • K880212TSRH H/M Hook Holder W/Rod MoverWarsaw Orthopedic, Inc. · 1988
  • K880215TSRH H/M Hook, Eyebolt/Lock Nut Assem., Spinal RodWarsaw Orthopedic, Inc. · 1988
  • K880214TSRH H/M Torque Limiting WrenchWarsaw Orthopedic, Inc. · 1988
  • K870843Schultz Phalangeal Comp Trial/Metacarpal Comp TriaWarsaw Orthopedic, Inc. · 1987

All 24 as Warsaw Orthopedic, Inc. →