FDA 510(k) clearance · back to tracker

Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System

Kyocera Medical Technologies, Inc. cleared K261353 on 2026-07-15, decision: substantially equivalent

K-number

K261353

Sponsor

Kyocera Medical Technologies, Inc.

Device

Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-07-15

Product code

OVD

Advisory committee

Orthopedic

Medical specialty

Orthopedic

Regulation number

888.3080

Official FDA record

Open K261353on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.