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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
Applicant
OSTEOTECH, INC.
51 james way
eatontown,  NJ  07724
Applicant Contact kim thurman
Correspondent
OSTEOTECH, INC.
51 james way
eatontown,  NJ  07724
Correspodent 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
Type Special
Reviewed by Third Party No
Combination Product No
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