FDA applicant
Stryker Leibinger GmbH & Co KG
FDA records 36 decisions for Stryker Leibinger GmbH & Co KG (Kalamazoo, MI) from 1999 to 2026: 35 510(k) clearances and 1 original PMA approval. Most are in product codes OLO (Orthopedic Stereotaxic Instrument) and HRS (Plate, Fixation, Bone). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 59 predicates, 16 of them its own earlier devices. 13 recalls are linked to its devices.
FDA’s records also spell it “Stryker Leibinger”, “Stryker Leibinger GmbH”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Stryker Leibinger GmbH & Co KG’s devices, and how often a recall has named them.
FDA decisions per year
6in 2024
2026 so far, outlined.
Recalls per year
1in 2024
Class I Class II/III not classified
Planning a device like Stryker Leibinger GmbH & Co KG’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Stryker”
FDA records each applicant name separately; these may or may not be the same firm.