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510(k) K101730

LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS by Zimmer, Inc. — Product Code KWZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2010
Date Received
June 18, 2010
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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