K254110
- 510(k) number
- K254110
- Device name
- DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro
- Applicant
- MedShape, Inc. GA · US
- Product code
- HWC — Screw, Fixation, Bone
- Decision date
- 2026-03-18
- Date received
- 2025-12-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K254110.pdf
Official FDA record: K254110
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.