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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, lumbar
510(k) Number K151483
Device Name Biomet Spine Fusion System
Applicant
Biomet Spine LLC.
310 Interlocken Parkway, Suite 120
Broomfield,  CO  80021
Applicant Contact Ted Kuhn
Correspondent
Biomet Spine LLC.
310 Interlocken Parkway, Suite 120
Broomfield,  CO  80021
Correspondent Contact Ted Kuhn
Regulation Number888.3080
Classification Product Code
MAX  
Date Received06/02/2015
Decision Date 07/31/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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