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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 K151224
Device Name Lineum OCT Spine System
Applicant
BIOMET SPINE
310 INTERLOCKEN PARKWAY, SUITE 120
BROOMFIELD,  CO  80021
Applicant Contact Spencer Kimber
Correspondent
BIOMET SPINE
310 INTERLOCKEN PARKWAY, SUITE 120
BROOMFIELD,  CO  80021
Correspondent Contact Spencer Kimber
Regulation Number888.3075
Classification Product Code
NKG  
Subsequent Product Code
KWP  
Date Received05/07/2015
Decision Date 06/30/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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