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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 Intervertebral Body
510(k) Number K943725
Device Name UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM
Applicant
Synthes Spine
P.O. Box 0548
1690 Russell Rd.
Paoli,  PA  19301
Applicant Contact DIANE BROWN
Correspondent
Synthes Spine
P.O. Box 0548
1690 Russell Rd.
Paoli,  PA  19301
Correspondent Contact DIANE BROWN
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received08/01/1994
Decision Date 08/25/1995
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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