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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 K240250
Device Name 3D Printed PEEK Interbody System
Applicant
Nvision Biomedical Technologies, Inc.
4590 Lockhill Selma
San Antonio,  TX  78249
Applicant Contact Diana Langham
Correspondent
Watershed Idea Foundry, Inc. (Dba Spitrex 3D)
1815 Aston Ave., Suite 106
Carlsbad,  CA  92008
Correspondent Contact Jeffrey Brittan
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
ODP  
Date Received01/30/2024
Decision Date 09/17/2024
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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