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FDA 510(k) Application Details - K094037
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K094037
Device Name
Plate, Fixation, Bone
Applicant
ORTHO-PRO LLC
1001 OAKWOOD BLVD
ROUND ROCK, TX 78681 US
Other 510(k) Applications for this Company
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
12/30/2009
Decision Date
03/10/2010
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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