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FDA 510(k) Application Details - K121356
Device Classification Name
Fastener, Fixation, Nondegradable, Soft Tissue
More FDA Info for this Device
510(K) Number
K121356
Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Applicant
ANULEX TECHNOLOGIES, INC
5600 ROWLAND ROAD, STE 280
MINNETONKA, MN 55343 US
Other 510(k) Applications for this Company
Contact
RACHEL KENNEDY
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
05/04/2012
Decision Date
11/09/2012
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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