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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K233089
Device Name NeoSpan® Compression Implant System
Applicant
In2bones USA, LLC
6000 Poplar Ave., Suite 115
Memphis,  TN  38002
Applicant Contact Christine Scifert
Correspondent
In2bones USA, LLC
6000 Poplar Ave., Suite 115
Memphis,  TN  38002
Correspondent Contact Christine Scifert
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HWC   JDR  
Date Received09/26/2023
Decision Date 05/24/2024
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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