Scala® TL
FDA 510(k) K261049 · Spineart SA
510(k) numberK261049
Submission
- Device name
- Scala® TL
- Applicant
- Spineart SA
Plan-Les-Ouates, CH - Received
- March 31, 2026
- Decision date
- August 20, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
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|---|---|---|---|
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|---|---|---|
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| K254158 | SPINEART Navigation Instrument SystemOLO · Special | 04/09/2026SE |
| K242933 | SPINEART Navigation Instrument SystemOLO · Traditional | 06/18/2025SE |
| K242890 | SPINEART Navigation Instrument SystemOLO · Traditional | 03/07/2025SE |
| K242589 | Scarlet® AL-TMAX · Traditional | 10/23/2024SE |
| K241644 | SPINEART Navigation Instrument SystemOLO · Special | 08/07/2024SE |
| K241321 | Juliet® Ti LL Lumbar Interbody DeviceOVD · Traditional | 07/18/2024SE |
| K240699 | SCARLET® AC-TiOVE · Traditional | 05/10/2024SE |
Questions and answers
When was Scala® TL cleared by the FDA?
Scala® TL (K261049) received a 510(k) decision of Substantially Equivalent on August 20, 2026, 142 days after the submission was received.
What is the product code of K261049?
The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.