K251131
- 510(k) number
- K251131
- Device name
- Annex® 2 Adjacent Level System
- Applicant
- Spine Wave, Inc. CT · US
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2025-06-06
- Date received
- 2025-04-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K251131.pdf
Official FDA record: K251131
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.