FDA applicant
I.T.S. GmbH
FDA records 8 decisions for I.T.S. GmbH (Laßnitzhöhe, AT) from 2013 to 2026: 8 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HSB (Rod, Fixation, Intramedullary And Accessories). Since 2016 its 510(k)s took a median of 122 days from receipt to decision, against 113 for FDA’s reviews in the same codes and years. Its devices cite 81 predicates, 8 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
How often FDA has decided I.T.S. GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
5in 2026
Class I Class II/III not classified
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