K254087
- 510(k) number
- K254087
- Device name
- MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System
- Applicant
- Synthes (USA) Products, LLC PA · US
- Product code
- KTT — Appliance, Fixation, Nail/Blade/Plate Combination, M
- Decision date
- 2026-06-11
- Date received
- 2025-12-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K254087.pdf
Official FDA record: K254087
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.