FDA applicant
I.T.S. Implantat-Technologie-Systeme GmbH
FDA records 13 decisions for I.T.S. Implantat-Technologie-Systeme GmbH (Prior Lake, MN) from 2004 to 2010: 13 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and JDS (Nail, Fixation, Bone). Its devices cite 59 predicates, 5 of them its own earlier devices. 13 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. Implantat-Technologie-Systeme GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2010
2026 so far, outlined.
Recalls per year
12in 2026
Class I Class II/III not classified
Planning a device like I.T.S. Implantat-Technologie-Systeme…’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) Report