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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Integrated Fixation, Lumbar
510(k) Number K261353
Device Name Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System
Applicant
Kyocera Medical Technologies, Inc.
1289 Bryn Mawr Ave., Suite A.
Redlands,  CA  92374
Applicant Contact Scott Rucker
Correspondent
ATS Colorado Springs
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Hannah Taggart
Regulation Number888.3080
Classification Product Code
OVD  
Subsequent Product Code
MAX  
Date Received04/24/2026
Decision Date 07/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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