K232905
- 510(k) number
- K232905
- Device name
- Medline UNITE® REFLEX® Nitinol Staple Kit
- Applicant
- Medline Industries, LP IL · US
- Product code
- JDR — Staple, Fixation, Bone
- Decision date
- 2023-10-19
- Date received
- 2023-09-19
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K232905.pdf
Official FDA record: K232905
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.