K260277
- 510(k) number
- K260277
- Device name
- MIKRON TRAUMA BONE PLATE& SCREW SYSTEM
- Applicant
- Mikron Makina San. ve Tic. Ltd. Sti. TR
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2026-08-13
- Date received
- 2026-01-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K260277.pdf
Official FDA record: K260277
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.