510(k) Report

FDA applicant

Osteo Technology, Inc.

Timonium, MD18 decisions1992–19940 recalls

FDA records 18 decisions for Osteo Technology, Inc. (Timonium, MD) from 1992 to 1994: 18 510(k) clearances. Most are in product codes JDI (Prosthesis, Hip, Semi-Constrained…) and JWH (Prosthesis, Knee, Patellofemorotibial…). 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 Technology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Osteo Technology, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Osteo Technology, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Osteo”

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