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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spinal Pedicle Fixation
510(k) Number K000450
Device Name MODIFICATION TO SYNTHES USS
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 Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   KWQ   MNH  
Date Received02/11/2000
Decision Date 03/10/2000
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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