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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 K063668
Device Name ROC LUMBAR SYSTEM
Applicant
Alphatec Spine, Inc.
2051 Palomar Airport Rd.
Suite 100
Carlsbad,  CA  92011
Applicant Contact PAULA MORGAN
Correspondent
Alphatec Spine, Inc.
2051 Palomar Airport Rd.
Suite 100
Carlsbad,  CA  92011
Correspondent Contact PAULA MORGAN
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received12/11/2006
Decision Date 05/18/2007
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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