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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 K950865
Device Name ROGOZINSKI SPINAL ROD SYSTEM ROD-TO-BOLT (UNIVERSAL) CONNECTOR FOR USE WITH THE SIMMONS PLATING SYSTEM BOLT
Applicant
Smith & Nephew Richards, Inc.
1450 E. Brooks Rd.
Memphis,  TN  38116
Applicant Contact JEFF COBB
Correspondent
Smith & Nephew Richards, Inc.
1450 E. Brooks Rd.
Memphis,  TN  38116
Correspondent Contact JEFF COBB
Regulation Number888.3070
Classification Product Code
MNH  
Date Received02/27/1995
Decision Date 09/01/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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