510(k) Report

FDA applicant

Stryker Leibinger Micro Implants

Portage, MI2 decisions2005–20220 recalls

FDA records 2 decisions for Stryker Leibinger Micro Implants (Portage, MI) from 2005 to 2022: 2 510(k) clearances. Most are in product codes MQV (Filler, Bone Void, Calcium Compound) and JEY (Plate, Bone). Its devices cite 4 predicates, 0 of them its own earlier devices. 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 Stryker Leibinger Micro Implants’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Stryker Leibinger Micro Implants by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Stryker”

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