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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 K050804
Device Name MODIFICATION TO: SPECTRUMTM CERVICAL SPINAL SYSTEM
Applicant
AESCULAP, INC.
3773 Corporate Parkway
Center Valley,  PA  18034
Applicant Contact KATHY A RACOSKY
Correspondent
AESCULAP, INC.
3773 Corporate Parkway
Center Valley,  PA  18034
Correspondent Contact KATHY A RACOSKY
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received03/30/2005
Decision Date 04/11/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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