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510(k) K122139

SMITH & NEPHEW R3 CONSTRAINED LINERS by Smith & Nephew, Inc. — Product Code KWZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2012
Date Received
July 19, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3310
Review Panel
OR
Submission Type

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