Scala® Tl
by Spineart
510(k) K261049
Scala® Tl is a Class II device made by Spineart, cleared under FDA 510(k) K261049 on 20 Aug 2026, active as of 8 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK261049 | Date20 Aug 2026 | StatusActive |
Official records
- FDA 510(k) database K261049
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MAX
- FDA applicant
- Spineart SA
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar).
- Conduit Lateral Switch Plate by MEDOS INTERNATIONAL SARL
- Camber Spine Diagon Oblique Cage by Camber Spine
- INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers by GLOBUS MEDICAL, INC.
- TxTi IBF System by Innovasis, Inc.
- NavLock™ 9734835 by Medtronic Navigation Inc.
- Innesis PEEK TL Cage by BK MEDITECH CO., LTD.
- Rampart L Lumbar Interbody Fusion Device by SPINEOLOGY INC.
- Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System by Zavation Medical Products, LLC
- Catalyft PL Expandable Interbody System by Medtronic Sofamor Danek USA, Incorporated
- CONCORDE 187827409 by MEDOS INTERNATIONAL SARL