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FDA 510(k)

SCALA® TL

K-Number: K261049 · 2026-08-20

ApplicantSpineart SA
Decision Date2026-08-20
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SCALA® TL is the device name listed in this FDA 510(k) record. The listed applicant is Spineart SA. It received FDA 510(k) clearance on 2026-08-20 under 510(k) number K261049. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCALA® TL?

SCALA® TL is a medical device that received FDA 510(k) clearance on 2026-08-20. The listed applicant is Spineart SA. The 510(k) number is K261049.

When did SCALA® TL receive FDA 510(k) clearance?

SCALA® TL received FDA 510(k) clearance on 2026-08-20, under 510(k) number K261049.

Who is the listed applicant for SCALA® TL?

The FDA 510(k) record lists Spineart SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCALA® TL?

The FDA product code for SCALA® TL is MAX.

Other records listing Spineart SA as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262639BAGUERA® C Cervical Disc Surgical InstrumentsK261205SPINEART Navigation Instrument SystemK253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemK254158SPINEART Navigation Instrument SystemK242933SPINEART Navigation Instrument SystemK242890SPINEART Navigation Instrument System

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Related Devices (Code: MAX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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