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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name spinal vertebral body replacement device
510(k) Number K003836
Device Name SYNTHES SYNEX SPACER SYSTEM
Applicant
SYNTHES
1690 RUSSELL RD.
PAOLI,  PA  19301
Applicant Contact JONATHAN GILBERT
Correspondent
SYNTHES
1690 RUSSELL RD.
PAOLI,  PA  19301
Correspondent Contact JONATHAN GILBERT
Regulation Number888.3060
Classification Product Code
MQP  
Date Received12/12/2000
Decision Date 05/29/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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