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510(k) K061654

TRIDENT CONSTRAINED ACETABULAR INSERT by Howmedica Osteonics Corp. — Product Code KWZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 2006
Date Received
June 13, 2006
Clearance Type
Special
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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