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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 Bone Graft, Lumbar
510(k) Number K242771
Device Name Tesera-k PL System and Tesera-k XL System
Applicant
Kyocera Medical Technologies, Inc.
1289 Bryn Mawr Ave.
Suite A
Redlands,  CA  92374
Applicant Contact Dennis Ty
Correspondent
Empirical Technologies
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Nathan Wright
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
OVD  
Date Received09/13/2024
Decision Date 03/20/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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