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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 K000742
Device Name SYNTHES ANTERIOR CSLP SYSTEM
Applicant
Synthes Spine
P.O. Box 0548
1690 Russell Rd.
Paoli,  PA  19301
Applicant Contact JONATHAN GILBERT
Correspondent
Synthes Spine
P.O. Box 0548
1690 Russell Rd.
Paoli,  PA  19301
Correspondent Contact JONATHAN GILBERT
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received03/07/2000
Decision Date 03/29/2000
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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