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510(k) K181778

MUTARS Proximal Femur Replacement System by Implantcast GmbH — Product Code MEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2019
Date Received
July 3, 2018
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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