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FDA 510(k) Application Details - K160118
Device Classification Name
Fastener, Fixation, Nondegradable, Soft Tissue
More FDA Info for this Device
510(K) Number
K160118
Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Applicant
CROSSROADS EXTREMITY SYSTEMS, LLC
6055 PRIMACY PKWY SUITE 140
MEMPHIS, TN 38119 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
MBI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/19/2016
Decision Date
05/03/2016
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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