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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 K091531
Device Name CHOICE SPINE CERVICAL INTERBODY SPACER SYSTEM CHOICE SPINE CERVICAL INTERBODY SPACER
Applicant
Choice Spine, Llp
306 Erin Dr.
Knoxville,  TN  37919
Applicant Contact G.TODD HAWKINS
Correspondent
Choice Spine, Llp
306 Erin Dr.
Knoxville,  TN  37919
Correspondent Contact G.TODD HAWKINS
Regulation Number888.3080
Classification Product Code
ODP  
Date Received05/26/2009
Decision Date 11/02/2009
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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