510(k) Report

FDA applicant

Osteotomy Guide Co.

Mesa, AZ3 decisions1984–19860 recalls

FDA records 3 decisions for Osteotomy Guide Co. (Mesa, AZ) from 1984 to 1986: 3 510(k) clearances. Most are in product codes HTH (Protractor) 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 Osteotomy Guide Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Osteotomy Guide Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Osteotomy Guide Co. 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?

  • HTHProtractor2decisions
  • HWCScrew, Fixation, Bone1decision

What has FDA decided for it lately?

  • K861576Shortening Osteotomy GuideOsteotomy Guide Co. · 1986
  • K860323Reese Arthrodesis ScrewOsteotomy Guide Co. · 1986
  • K841470Reese Osteotomy Guide SysOsteotomy Guide Co. · 1984

All 3 as Osteotomy Guide Co. →