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FDA 510(k) Application Details - K183696
Device Classification Name
More FDA Info for this Device
510(K) Number
K183696
Device Name
Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid
Applicant
Tornier, Inc.
10801 Nesbitt Avenue South
Bloomington, MN 55347 US
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Contact
Moyees Kamara
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Regulation Number
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Classification Product Code
PHX
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Date Received
12/31/2018
Decision Date
01/30/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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