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FDA 510(k) Application Details - K121136
Device Classification Name
Appliance, Fixation, Spinal Interlaminal
More FDA Info for this Device
510(K) Number
K121136
Device Name
Appliance, Fixation, Spinal Interlaminal
Applicant
ACCEL SPINE
14850 Quorum Dr Ste 220
Dallas, TX 75254 US
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Contact
DANIEL CHON
Other 510(k) Applications for this Contact
Regulation Number
888.3050
More FDA Info for this Regulation Number
Classification Product Code
KWP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/13/2012
Decision Date
08/09/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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