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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Posterior Metal/Polymer Spinal System, Fusion
510(k) Number K043565
Device Name MODIFICATION TO DYNESYS SPINAL SYSTEM
Applicant
ZIMMER SPINE, INC
7375 BUSH LAKE RD.
MINNEAPOLIS,  MN  55439 -2027
Applicant Contact TIM CRABTREE
Correspondent
ZIMMER SPINE, INC
7375 BUSH LAKE RD.
MINNEAPOLIS,  MN  55439 -2027
Correspondent Contact TIM CRABTREE
Regulation Number888.3070
Classification Product Code
NQP  
Date Received12/27/2004
Decision Date 03/11/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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