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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 integrated fixation, lumbar
510(k) Number K082926
Device Name ZUMA, MODEL 55-XXXX/56-XXXX
Applicant
SEASPINE, INC.
2302 LA MIRADA DR.
vista,  CA  92081 -7862
Applicant Contact jeff brittan
Correspondent
SEASPINE, INC.
2302 LA MIRADA DR.
vista,  CA  92081 -7862
Correspondent Contact jeff brittan
Regulation Number888.3080
Classification Product Code
OVD  
Subsequent Product Code
MQP  
Date Received10/01/2008
Decision Date 12/22/2008
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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