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510(k) K121315

STRYKER CMF MEDPOR CUSTOMIZED IMPLANT by Howmedica Osteonics Corp. — Product Code FWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2012
Date Received
May 2, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Chin, Internal
Device Class
Class II
Regulation Number
878.3550
Review Panel
SU
Submission Type

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