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FDA 510(k) Application Details - K141857
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K141857
Device Name
Screw, Fixation, Bone
Applicant
ORTHODISCOVERY GROUP LLC (D.B.A. CROSSROADS EXTREM
458 DISTRIBUTION PKWY
COLLIERVILLE, TN 38017 US
Other 510(k) Applications for this Company
Contact
VERNON HARTDEGEN
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
HWC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/10/2014
Decision Date
01/08/2015
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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