K231069
- 510(k) number
- K231069
- Device name
- PERLA® TL Posterior Thoraco-lumbar Fixation System
- Applicant
- Spineart SA CH
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2023-10-25
- Date received
- 2023-04-14
- 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: K231069.pdf
Official FDA record: K231069
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.