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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name intervertebral fusion device with bone graft, lumbar
510(k) Number K101085
Device Name SPINESMITH CYNCH SPINAL SYSTEM
Applicant
SPINE SMITH PARTNERS L.P.
5300 NORTH LAMAR BLVD #107
AUSTIN,  TX  78751
Applicant Contact LAURA LEBOEUF
Correspondent
SPINE SMITH PARTNERS L.P.
5300 NORTH LAMAR BLVD #107
AUSTIN,  TX  78751
Correspondent Contact LAURA LEBOEUF
Regulation Number888.3080
Classification Product Code
MAX  
Date Received04/19/2010
Decision Date 07/01/2010
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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