K233531
- 510(k) number
- K233531
- Device name
- OIC FLEX-FIX System
- Applicant
- Orthopaedic Implant Company NV · US
- Product code
- HTN — Washer, Bolt Nut
- Decision date
- 2024-02-02
- Date received
- 2023-11-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K233531.pdf
Official FDA record: K233531
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.