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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Posterior Metal/Polymer Spinal System, Fusion
510(k) Number K061774
Device Name NFIX II PEDICLE SCREW SYSTEM
Applicant
N Spine, Inc.
13221 Maricotte Place
San Diego,  CA  92130
Applicant Contact R. STEPHEN REITZLER
Correspondent
N Spine, Inc.
13221 Maricotte Place
San Diego,  CA  92130
Correspondent Contact R. STEPHEN REITZLER
Regulation Number888.3070
Classification Product Code
NQP  
Date Received06/23/2006
Decision Date 12/13/2006
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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