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FDA 510(k) Application Details - K171911
Device Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
More FDA Info for this Device
510(K) Number
K171911
Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant
Surgical Instrument Service and Savings Inc
(dba Medline ReNewal)
1500 NE Hemlock Ave.
Redmond, OR 97756 US
Other 510(k) Applications for this Company
Contact
Stephanie Boyle Mays
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
KTT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/26/2017
Decision Date
11/09/2017
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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