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510(k) K191569

Implantcast ic-Bipolar Head System by Implantcast GmbH — Product Code KWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2019
Date Received
June 13, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Device Class
Class II
Regulation Number
888.3390
Review Panel
OR
Submission Type

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