FDA applicant

Orthopedic Sciences, Inc.

Seal Beach, CA11 decisions2002–20140 recalls

FDA records 11 decisions for Orthopedic Sciences, Inc. (Seal Beach, CA) from 2002 to 2014: 11 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HRX (Arthroscope). Its devices cite 24 predicates, 8 of them its own earlier devices. 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 Orthopedic Sciences, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Orthopedic Sciences, 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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Orthopedic Sciences, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?