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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 K965224
Device Name EMPOWER ANTERIOR DIRECT SCREWS
Applicant
Smith & Nephew Richards, Inc.
1450 E. Brooks Rd.
Memphis,  TN  38116
Applicant Contact THOMAS L CRAIG
Correspondent
Smith & Nephew Richards, Inc.
1450 E. Brooks Rd.
Memphis,  TN  38116
Correspondent Contact THOMAS L CRAIG
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Code
MNH  
Date Received12/30/1996
Decision Date 05/08/1997
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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