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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name thoracolumbosacral pedicle screw system
510(k) Number K121568
Device Name DALI SPINAL FIXATION SYSTEM
Applicant
ACCEL SPINE
14850 Quorum Dr Ste 220
Dallas,  TX  75254
Applicant Contact DANIEL CHON
Correspondent
ACCEL SPINE
14850 Quorum Dr Ste 220
Dallas,  TX  75254
Correspondent Contact DANIEL CHON
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received05/29/2012
Decision Date 09/21/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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