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I.T.S. GmbH

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
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 (L	HRS	2026-06-16	View
510(k)	K260054	I.T.S. PRS Phoenix II	HRS	2026-04-24	View
510(k)	K233134	I.T.S. INS Proximal Femur Nail	HSB	2024-02-12	View
510(k)	K210935	I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)	HRS	2022-08-31	View
510(k)	K131722	I.T.S. EXTREMITY FIXATION SYSTEMS	HRS	2013-08-07	View
510(k)	K130008	DISTAL ULNA LOCKING PLATE (DUL), ULNA OSTEOTOMY LOCKING PLATE (UOL), 3.0 CANCELLOUS LOCKING SCREW, 3.0 CORTICAL LOCKING	HRS	2013-06-25	View

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