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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 Interlaminal
510(k) Number K993067
Device Name SILHOUETTE SPINAL FIXATION SYSTEM
Applicant
Sulzer Spine-Tech
7375 Bush Lake Rd.
Minneapolis,  MN  55439 -2027
Applicant Contact JANELL A COLLEY
Correspondent
Sulzer Spine-Tech
7375 Bush Lake Rd.
Minneapolis,  MN  55439 -2027
Correspondent Contact JANELL A COLLEY
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
MNH   MNI  
Date Received09/13/1999
Decision Date 11/16/1999
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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