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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K973586
Device Name SPINAL CONCEPTS, INC., UNIVERSAL BONE PLATE SYSTEM II
Applicant
Spinal Concepts, Inc.
820o Cameron Rd., Suite B-160
Austin,  TX  78754
Applicant Contact TEENA M AUGOSTINO
Correspondent
Spinal Concepts, Inc.
820o Cameron Rd., Suite B-160
Austin,  TX  78754
Correspondent Contact TEENA M AUGOSTINO
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HRS  
Date Received09/22/1997
Decision Date 11/07/1997
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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