K243816
- 510(k) number
- K243816
- Device name
- Testa TP Pivoting Spacer System
- Applicant
- Spine Wave, Inc. CT · US
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2025-06-27
- Date received
- 2024-12-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K243816.pdf
Official FDA record: K243816
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.