510(k) Report

FDA applicant

Advanced Med/Surg, Inc.

Hayward, CA10 decisions1991–19940 recalls

FDA records 10 decisions for Advanced Med/Surg, Inc. (Hayward, CA) from 1991 to 1994: 10 510(k) clearances. Most are in product codes LXH (Orthopedic Manual Surgical Instrument) and HWC (Screw, Fixation, Bone). 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 Advanced Med/Surg, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Advanced Med/Surg, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Advanced Med/Surg, 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?

  • LXHOrthopedic Manual Surgical Instrument4decisions
  • HWCScrew, Fixation, Bone2decisions
  • HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment1decision
  • KWQAppliance, Fixation, Spinal Intervertebral Body1decision
  • IZGSystem, X-Ray, Photofluorographic1decision
  • HRXArthroscope1decision

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.

  • K905023Amset Locking Plate SystemAdvanced Med/Surg, Inc. · 19921cites it

What has FDA decided for it lately?

  • K942108Cohort Bone BrushAdvanced Med/Surg, Inc. · 1994
  • K931538Amset (TM) Cannulated Bone ScrewAdvanced Med/Surg, Inc. · 1994
  • K921643Amsen Posterior Disc EvacuatorAdvanced Med/Surg, Inc. · 1992
  • K921645Amsen Spine Impactor InstrumentsAdvanced Med/Surg, Inc. · 1992
  • K921642Amsen Double-Ended Foraminal ProbeAdvanced Med/Surg, Inc. · 1992
  • K921644Amsen Hockey Stick ChiselAdvanced Med/Surg, Inc. · 1992
  • K905023Amset Locking Plate SystemAdvanced Med/Surg, Inc. · 1992
  • K911768Amset (TM) Bone ScrewAdvanced Med/Surg, Inc. · 1991

All 10 as Advanced Med/Surg, Inc. →