K241863
- 510(k) number
- K241863
- Device name
- Erisma® Lp Spinal Fixation System; Erisma® LP MIS
- Applicant
- Clariance FR
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2024-07-24
- Date received
- 2024-06-27
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K241863.pdf
Official FDA record: K241863
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.