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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spondylolisthesis Spinal Fixation
510(k) Number K974749
Device Name SYNERGY CLOSED VARIABLE LOCKING SCREW (VLS), PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR AND POSTERIOR SPINAL SYSTEMS
Applicant
Cross Medical Products, Inc.
5160-A Blazer Pkwy.
Suite A
Dublin,  OH  43017 -1339
Applicant Contact PHIL MELLINGER
Correspondent
Cross Medical Products, Inc.
5160-A Blazer Pkwy.
Suite A
Dublin,  OH  43017 -1339
Correspondent Contact PHIL MELLINGER
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   KWQ  
Date Received12/19/1997
Decision Date 03/13/1998
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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