SCALA® TL— 510(k) K261049
Substantially EquivalentSpineart SA
FDA 510(k) clearance K261049 for SCALA® TL, Substantially Equivalent on 2026-08-20. Applicant: Spineart SA. Device class: 2.
Summary
Spineart's SCALA TL is filed under product code MAX, lumbar intervertebral fusion devices with bone graft. The record gives no model numbers and doesn't say what TL stands for.
Class II, 21 CFR 888.3080. Orthopedic is both the classification panel and the review panel. It came in as a Traditional 510(k).
Spineart filed from Plan-Les-Ouates, Switzerland. Review took 142 calendar days (March 31 to August 20, 2026) and ended in a substantially equivalent decision.
Clearance details
- Applicant
- Spineart SA
- Product code
- Product code MAX
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plan-Les-Ouates, CH
Recent devices under product code MAX
view allMore clearances from Spineart SA
view allAdverse events under product code MAX
product code MAX- Death
- 13
- Injury
- 1,305
- Malfunction
- 2,885
- Total
- 4,203
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.