FDA applicant

Surgical Planning Associates, Inc.

Boston, MA3 decisions2010–20240 recalls

FDA records 3 decisions for Surgical Planning Associates, Inc. (Boston, MA) from 2010 to 2024: 3 510(k) clearances. All are in product code OSF (Patient Specific Manual Orthopedic Stereotaxic…). Its devices cite 2 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Surgical Planning Associates”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Surgical Planning Associates, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Surgical Planning Associates, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Surgical Planning Associates, 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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Surgical Planning Associates, Inc.

Which product codes does it file in?

Which of its devices are cited most?

What has FDA decided for it lately?