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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 Integrated Fixation, Cervical
510(k) Number K223869
Device Name ChoiceSpine Blackhawk Ti Cervical Spacer System
Applicant
Choice Spine, LLC
400 Erin Dr.
Knoxville,  TN  37919
Applicant Contact Kim Finch
Correspondent
Choice Spine, LLC
400 Erin Dr.
Knoxville,  TN  37919
Correspondent Contact Kim Finch
Regulation Number888.3080
Classification Product Code
OVE  
Date Received12/23/2022
Decision Date 09/14/2023
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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