K253966
- 510(k) number
- K253966
- Device name
- PERLA® TL Posterior Thoraco-lumbar Fixation System
- Applicant
- Spineart SA CH
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2026-05-01
- Date received
- 2025-12-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K253966.pdf
Official FDA record: K253966
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.