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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, Cervical
510(k) Number K191621
Device Name ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octane Straight, ChoiceSpine Intervertebral Fusion Device Octane Straight PC, ChoiceSpine VEO Laterial Access & Interbody Fusion 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
ODP  
Subsequent Product Codes
MAX   OVE  
Date Received06/18/2019
Decision Date 08/15/2019
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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