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FDA 510(k) Application Details - K073228
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K073228
Device Name
Plate, Fixation, Bone
Applicant
ORTHOPRO LLC
1001 OAKWOOD BLVD.
ROUND ROCK, TX 78681 US
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Contact
J.D. WEBB
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
11/15/2007
Decision Date
02/29/2008
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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