K232990
- 510(k) number
- K232990
- Device name
- ATOMIC Nitinol Fixation System
- Applicant
- Rmr Ortho, LLC TX · US
- Product code
- JDR — Staple, Fixation, Bone
- Decision date
- 2024-01-12
- Date received
- 2023-09-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K232990.pdf
Official FDA record: K232990
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.