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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, Cervical
510(k) Number K081730
Device Name NOVEL CERVICAL SPINAL SPACER SYSTEM
Applicant
Alphatec Spine, Inc.
2051 Palomar Airport Rd.
Suite 100
Carlsbad,  CA  92011
Applicant Contact MARY SCANNERS
Correspondent
Alphatec Spine, Inc.
2051 Palomar Airport Rd.
Suite 100
Carlsbad,  CA  92011
Correspondent Contact MARY SCANNERS
Regulation Number888.3080
Classification Product Code
ODP  
Date Received06/18/2008
Decision Date 09/19/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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