K240872
- 510(k) number
- K240872
- Device name
- Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System
- Applicant
- Clariance FR
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2024-04-26
- Date received
- 2024-03-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K240872.pdf
Official FDA record: K240872
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.