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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 K232014
Device Name CONDUIT™ ATP Inserters
Applicant
Enztec Limited
3/17 Print Place
Middleton
Christchurch,  NZ 8024
Applicant Contact James Sheat
Correspondent
Empirical Technologies
4628 Northpark Drive
Colorado Springs,  CO  80918
Correspondent Contact Nathan Wright
Regulation Number888.3080
Classification Product Code
MAX  
Date Received07/06/2023
Decision Date 09/01/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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