FDA applicant

Integrum AB

Mölndal1 decision2020–20200 recalls

FDA records 1 decision for Integrum AB (Mölndal) in 2020: 1 original PMA approval. All are in product code PJY (Osseoanchored Prostheses For The…). 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 Integrum AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Integrum AB by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Integrum AB

Which product codes does it file in?

What has FDA decided for it lately?