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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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