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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 K032812
Device Name ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT
Applicant
ORTHOVITA, INC.
45 GREAT VALLEY PKWY.
MALVERN,  PA  19355
Applicant Contact DAVID J MCILHENNY
Correspondent
ORTHOVITA, INC.
45 GREAT VALLEY PKWY.
MALVERN,  PA  19355
Correspondent Contact DAVID J MCILHENNY
Regulation Number888.3060
Classification Product Code
MQP  
Date Received09/09/2003
Decision Date 12/08/2003
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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