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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 K142634
Device Name Biomet Spine Fusion System
Applicant
Biomet Spine, LLC
310 Interlocken Pkwy. Suite 120
Broomfield,  CO  80021
Applicant Contact Mike Medina
Correspondent
Biomet Spine, LLC
310 Interlocken Pkwy. Suite 120
Broomfield,  CO  80021
Correspondent Contact Mike Medina
Regulation Number888.3080
Classification Product Code
MAX  
Date Received09/17/2014
Decision Date 03/12/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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