510(k) Report

FDA applicant

Osteo AG

Greenwood, SC9 decisions1991–19940 recalls

FDA records 9 decisions for Osteo AG (Greenwood, SC) from 1991 to 1994: 9 510(k) clearances. Most are in product codes HSB (Rod, Fixation, Intramedullary And Accessories) and HTY (Pin, Fixation, Smooth). 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 Osteo AG’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Osteo AG since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Osteo AG by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Osteo”

FDA records each applicant name separately; these may or may not be the same firm.