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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
Recalls CDRH Recalls
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