K260054
- 510(k) number
- K260054
- Device name
- I.T.S. PRS Phoenix II
- Applicant
- I.T.S. GmbH AT
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2026-04-24
- Date received
- 2026-01-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K260054.pdf
Official FDA record: K260054
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.