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The Tracker / August 2026 / K261049

510(k) cleared

SCALA® TL

Spineart SA · Aug 20, 2026 · K261049

FDA cleared the SCALA® TL from Spineart SA on Aug 20, 2026 under K261049, a traditional 510(k). The device falls under product code MAX, Intervertebral Fusion Device With Bone Graft, Lumbar, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Mar 31, 2026. The decision came 142 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Spineart SA has 5 other decisions in the tracker over the last 12 months: K262639 (BAGUERA® C Cervical Disc Surgical Instruments), P250042 (BAGUERA®C Cervical Disc Prosthesis), K261205 (SPINEART Navigation Instrument System), K253966 (PERLA® TL Posterior Thoraco-lumbar Fixation System).

Questions & Answers

What did FDA clear under K261049?

K261049 is the FDA 510(k) for SCALA® TL, submitted by Spineart SA. FDA's decision date was Aug 20, 2026, under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar).

Who makes the SCALA® TL?

Spineart SA, based in Plan-Les-Ouates, is the applicant of record for K261049.

How long did the K261049 review take?

FDA received the submission on Mar 31, 2026 and issued its decision on Aug 20, 2026, 142 days later.

← All decisions in August 2026