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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Interlaminal
510(k) Number K103205
Device Name BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM
Applicant
Alphatec Spine, Inc.
2051 Palomar Airport Rd.
Suite 100
Carlsbad,  CA  92011
Applicant Contact OLGA LEWIS
Correspondent
Alphatec Spine, Inc.
2051 Palomar Airport Rd.
Suite 100
Carlsbad,  CA  92011
Correspondent Contact OLGA LEWIS
Regulation Number888.3050
Classification Product Code
KWP  
Date Received11/01/2010
Decision Date 06/02/2011
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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