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510(k) K200045

MUTARS Cemented Femoral Stems by Implantcast GmbH — Product Code MEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2020
Date Received
January 8, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

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