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FDA 510(k) Application Details - K201507
Device Classification Name
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
More FDA Info for this Device
510(K) Number
K201507
Device Name
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Applicant
Integra Lifesciences Corporation
11101 Metric Blvd
Austin, TX 78758 US
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Contact
Cassidy Lemkau
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Regulation Number
888.3110
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Classification Product Code
HSN
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More FDA Info for this Product Code
Date Received
06/05/2020
Decision Date
06/29/2020
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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