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510(k) K072575

TRIATHLON SCREW-FIXATION TIBIAL BASEPLATE by Stryker Orthopaedics — Product Code MBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2008
Date Received
September 13, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3565
Review Panel
OR
Submission Type

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