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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spinal Pedicle Fixation
510(k) Number K062934
Device Name SIERRA
Applicant
Seaspine, Inc.
2302 La Mirada Dr.
Vista,  CA  92081
Applicant Contact DIANA SMITH
Correspondent
Seaspine, Inc.
2302 La Mirada Dr.
Vista,  CA  92081
Correspondent Contact DIANA SMITH
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
KWP  
Date Received09/28/2006
Decision Date 11/16/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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