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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 K090376
Device Name SPINESMITH CYNCH SPINAL SYSTEM
Applicant
SPINE SMITH PARTNERS L.P.
8140 N. MOPAC
BLDG II, SUITE 120
AUSTIN,  TX  78759
Applicant Contact ROBERT JONES
Correspondent
SPINE SMITH PARTNERS L.P.
8140 N. MOPAC
BLDG II, SUITE 120
AUSTIN,  TX  78759
Correspondent Contact ROBERT JONES
Regulation Number888.3080
Classification Product Code
MAX  
Date Received02/17/2009
Decision Date 04/01/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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