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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K141500
Device Name OPTIO-C ANTERIOR CERVICAL SYSTEM
Applicant
Zimmer Spine, Inc.
7375 Bush Lake Rd.
Minneapolis,  MN  55439
Applicant Contact DONNA M SEMLAK
Correspondent
Zimmer Spine, Inc.
7375 Bush Lake Rd.
Minneapolis,  MN  55439
Correspondent Contact DONNA M SEMLAK
Regulation Number888.3060
Classification Product Code
KWQ  
Subsequent Product Code
OVE  
Date Received06/06/2014
Decision Date 09/23/2014
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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