FDA applicant

Sulzer Spine-Tech

Minneapolis, MN8 decisions1999–20021 recall

FDA records 8 decisions for Sulzer Spine-Tech (Minneapolis, MN) from 1999 to 2002: 7 510(k) clearances and 1 original PMA approval. Most are in product codes KWP (Appliance, Fixation, Spinal Interlaminal) and MAX (Intervertebral Fusion Device With Bone Graft…). Its devices cite 11 predicates, 4 of them its own earlier devices. 1 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 Sulzer Spine-Tech’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sulzer Spine-Tech since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sulzer Spine-Tech by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sulzer Spine-Tech’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 “Sulzer”

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

Sulzer Orthopedics, Inc. 45 Sulzer Calcitek, Inc. 9 Sulzer Dental, Inc. 9 Sulzer Intratherapeutics, Inc. 8 Sulzer Carbomedics, Inc. 8 Sulzer Oscor, Inc. 2

Sulzer Spine-Tech

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Sulzer”