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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Posterior Cervical Screw System
510(k) Number K170804
Device Name The Solstice OCT System
Applicant
Life Spine Inc.
13951 S Quality Drive
Huntley,  IL  60142
Applicant Contact Randy Lewis
Correspondent
Life Spine Inc.
13951 S Quality Drive
Huntley,  IL  60142
Correspondent Contact Randy Lewis
Regulation Number888.3075
Classification Product Code
NKG  
Subsequent Product Code
KWP  
Date Received03/17/2017
Decision Date 05/18/2017
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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