K252997
- 510(k) number
- K252997
- Device name
- HyperFlex® Bunion Correction System
- Applicant
- Hyperflex Medical MI · US
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2025-12-11
- Date received
- 2025-09-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K252997.pdf
Official FDA record: K252997
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.