K260958
- 510(k) number
- K260958
- Device name
- 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
- Applicant
- I.T.S. GmbH AT
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2026-06-16
- Date received
- 2026-03-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K260958.pdf
Official FDA record: K260958
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.