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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name appliance, fixation, spinal interlaminal
510(k) Number K093438
Device Name PARADIGM INTERSPINOUS FUSION PLATE
Applicant
PARADIGM SPINE, LLC
1331 H STREET NW
12TH FLOOR
WASHINGTON,  DC  20005
Applicant Contact JUSTIN EGGLETON
Correspondent
PARADIGM SPINE, LLC
1331 H STREET NW
12TH FLOOR
WASHINGTON,  DC  20005
Correspondent Contact JUSTIN EGGLETON
Regulation Number888.3050
Classification Product Code
KWP  
Date Received11/04/2009
Decision Date 10/06/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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