K231443
- 510(k) number
- K231443
- Device name
- Mini-OSTEO Pedicle Fixation System
- Applicant
- Osteomed Indústria E Comércio DE Implantes Ltda BR
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2023-11-21
- Date received
- 2023-05-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K231443.pdf
Official FDA record: K231443
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.