FDA applicant

Centerpulse Spine-Tech, Inc.

Minneapolis, MN4 decisions2002–20045 recalls

FDA records 4 decisions for Centerpulse Spine-Tech, Inc. (Minneapolis, MN) from 2002 to 2004: 4 510(k) clearances. Most are in product codes MQV (Filler, Bone Void, Calcium Compound) and KWQ (Appliance, Fixation, Spinal Intervertebral Body). Its devices cite 14 predicates, 0 of them its own earlier devices. 5 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 Centerpulse Spine-Tech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Centerpulse Spine-Tech, Inc. since 2007.

Recalls per year

4in 2012

2007high 4 (2012) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Centerpulse”

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

Centerpulse Orthopedics, Inc. 10

Centerpulse Spine-Tech, Inc.

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 “Centerpulse”