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I.T.S. GmbH

FDA 510(k) & PMA Approved Devices — 4 products

Total Devices4
Categories2
Latest FDA decision2026-06-16
TypeNumberDevice NameCodeDateActions
510(k) K260958 I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (LHRS2026-06-16 View
510(k) K260054 I.T.S. PRS Phoenix IIHRS2026-04-24 View
510(k) K233134 I.T.S. INS Proximal Femur NailHSB2024-02-12 View
510(k) K210935 I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)HRS2022-08-31 View