510(k) clearance
SCALA® TL
- 510(k) number
- K261049
- Applicant
- Spineart SA
- Decision date
- Aug 20, 2026
- Date received
- Mar 31, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- MAX
- Device type
- Intervertebral Fusion Device With Bone Graft, Lumbar
- Device class
- Class II
- Regulation
- 21 CFR 888.3080
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Plan-Les-Ouates, CH