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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name orthosis, spondylolisthesis spinal fixation
510(k) Number K003384
Device Name VERSALINK TITANIUM ROD-TO-ROD COUPLERS
Original Applicant
OSTEOTECH, INC.
51 james way
eatontown,  NJ  07724
Original Contact kim thurman
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   KWQ   MNI  
Date Received10/31/2000
Decision Date 11/24/2000
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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