K241359
- 510(k) number
- K241359
- Device name
- Medline UNITE® MIS Foot Recon Screw System
- Applicant
- Medline Industries, LP IL · US
- Product code
- HWC — Screw, Fixation, Bone
- Decision date
- 2024-08-02
- Date received
- 2024-05-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K241359.pdf
Official FDA record: K241359
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.