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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 Integrated Fixation, Lumbar
510(k) Number K163543
Device Name Biomet Fusion System
Applicant
Zimmer Biomet Spine, Inc.
310 Interlocken Pkwy. Suite 120
Broomfield,  CO  80021
Applicant Contact Megan Fessenden
Correspondent
Zimmer Biomet Spine, Inc.
310 Interlocken Pkwy. Suite 120
Broomfield,  CO  80021
Correspondent Contact Megan Fessenden
Regulation Number888.3080
Classification Product Code
OVD  
Subsequent Product Codes
MAX   MQP   ODP  
Date Received12/16/2016
Decision Date 02/28/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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