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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 K072685
Device Name NGARDE SYSTEM
Applicant
N SPINE, INC.
6244 FERRIS SQUARE, SUITE B
SAN DIEGO,  CA  92121 -3239
Applicant Contact JUDE V PAGANELLI
Correspondent
N SPINE, INC.
6244 FERRIS SQUARE, SUITE B
SAN DIEGO,  CA  92121 -3239
Correspondent Contact JUDE V PAGANELLI
Regulation Number888.3070
Classification Product Code
NQP  
Date Received09/21/2007
Decision Date 10/19/2007
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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