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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 K241438
Device Name Signus Tetris™ St; Signus Tetris™ R St
Applicant
SIGNUS Medizintechnik GmbH
Industriestrasse 2
Alzenau,  DE D-63755
Applicant Contact Antje Schmidt
Correspondent
JALEX Medical, LLC
27865 Clemens Road, Suite 3
Westlake,  OH  44145
Correspondent Contact Chhavy Tep-Cullison
Regulation Number888.3080
Classification Product Code
MAX  
Date Received05/21/2024
Decision Date 09/11/2024
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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