FDA applicant

Valorem Surgical

Douglassville, PA1 decision2015–2015144 recalls

FDA records 1 decision for Valorem Surgical (Douglassville, PA) in 2015: 1 510(k) clearance. All are in product code MNH (Orthosis, Spondylolisthesis Spinal Fixation). Its devices cite 1 predicate, 0 of them its own earlier devices. 144 recalls are 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 Valorem Surgical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

144in 2017

2015high 144 (2017) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Valorem Surgical by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Valorem Surgical

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?