FDA 510(k) clearance · back to tracker

Varion Thoracolumbar Fixation System

Kyocera Medical Technologies Inc. (KMTI) cleared K260989 on 2026-05-15, decision: substantially equivalent

K-number

K260989

Sponsor

Kyocera Medical Technologies Inc. (KMTI)

Device

Varion Thoracolumbar Fixation System

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-05-15

Product code

NKB

Advisory committee

Orthopedic

Medical specialty

Orthopedic

Regulation number

888.3070

Official FDA record

Open K260989on 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.