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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 K101471
Device Name AXLE INTERSPINOUS FUSION SYSTEM
Applicant
X-SPINE SYSTEMS, INC.
452 ALEXANDERSVILLE RD.
MIAMISBURG,  OH  45342
Applicant Contact DAVID KIRSCHMAN
Correspondent
X-SPINE SYSTEMS, INC.
452 ALEXANDERSVILLE RD.
MIAMISBURG,  OH  45342
Correspondent Contact DAVID KIRSCHMAN
Regulation Number888.3050
Classification Product Code
KWP  
Date Received05/27/2010
Decision Date 11/24/2010
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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