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FDA 510(k) Application Details - K102265
Device Classification Name
Appliance, Fixation, Spinal Intervertebral Body
More FDA Info for this Device
510(K) Number
K102265
Device Name
Appliance, Fixation, Spinal Intervertebral Body
Applicant
LDR SPINE USA
4030 WEST BRAKER LANE
SUITE 360
AUSTIN, TX 78759 US
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Contact
BECKINAM NOWATZKE
Other 510(k) Applications for this Contact
Regulation Number
888.3060
More FDA Info for this Regulation Number
Classification Product Code
KWQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/10/2010
Decision Date
09/29/2010
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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