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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 K003061
Device Name SYNTHES USS (10.0MM SIDE OPENING SCREWS)
Applicant
Synthes
1690 Russell Rd.
P.O. Box 1766
Paoli,  PA  19301
Applicant Contact JONATHAN GILBERT
Correspondent
Synthes
1690 Russell Rd.
P.O. Box 1766
Paoli,  PA  19301
Correspondent Contact JONATHAN GILBERT
Regulation Number888.3060
Classification Product Code
KWQ  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received10/02/2000
Decision Date 10/30/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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