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FDA 510(k) Application Details - K020611
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K020611
Device Name
Plate, Fixation, Bone
Applicant
SPINAL CONCEPTS, INC.
12012 TECHNOLOGY BLVD., #100
AUSTIN, TX 78727 US
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Contact
DAVID M HOOPER
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
HRS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/25/2002
Decision Date
03/27/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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